Mod 4 Appendix 1 Labor Categories updated 10 27 2023.pdf
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- Solicitation number
- 75F40123R00132
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This document outlines a federal indefinite delivery, indefinite quantity (IDIQ) contract opportunity issued by the Food and Drug Administration (FDA) to provide scientific support services in the health sector. The solicitation seeks proposals for a range of labor categories including scientific administrators, analysts, application developers, clinical trials coordinators, data analysts, engineers, evaluators, functional experts, investigators, and lab technicians. Qualifications for each labor category are specified along with required education and experience levels. The contract will have a five-year period of performance to provide on-demand professional services and subject matter expertise across FDA programs.
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Appendix 1: Labor Categories and Descriptions
The following appendix lists the labor categories and associated skill levels:
Labor Category and Skill Level Labor Category Descriptions Qualifications
Years of Experience
Scientific Admin Support I
Uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis, and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
BA degree in business, administration, public policy, public health, health science, economics communications, information technology (IT), accounting, biology, chemistry, microbiology, physics, statistics, botanicals, or related field. preferred in biopharmaceutical manufacturing, QA.
analytics, biotechnology research and development or other relevant research programs.
BA degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals, or related field. preferred in biopharmaceutical manufacturing, QA. analytics, biotechnology research and development or other relevant research program
Min 1 year experience
Scientific Admin Support
II
Uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With minimal direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
BA degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or related field. preferred in biopharmaceutical manufacturing, QA. analytics, biotechnology research and development or other relevant research program
Minimum 3-year experience
Scientific Admin Support
III
Uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With minimal direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
BA/MS degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or related field. preferred in biopharmaceutical manufacturing, QA. analytics, biotechnology research and development or other relevant research program
Minimum 5-year experience
Scientific Admin Support
IV
Uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With minimal direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
BA/MS degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or related field. preferred in biopharmaceutical manufacturing, QA. analytics, biotechnology research and development or other relevant research program
Minimum 8-year experience
Scientific Admin Support
V
Uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With minimal direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
BA/MS degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or related field. preferred in biopharmaceutical manufacturing, QA. analytics, biotechnology research and development or other relevant research program
Minimum 10- year experience
Analyst I
Under direction from project leaders, uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor’s degree in business administration, public policy, public health, health science, economics communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or another relevant field. Experience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research programs.
0 - 2
Years
Analyst II
Under minimal direction from project leaders, performs assignments of moderate complexity and works with greater independence uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With minimal direction from project leaders, performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor’s degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals, or another relevant field. Experience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research programs.
Minimum
Analyst III
Assists in identifying and interpreting data patterns and trends and assessing data quality. May develop and implement databases, data collection systems, data analytics, and other strategies that optimize statistical efficiency and quality. May act as the project lead, uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis, and assessment of qualitative and quantitative data, writing of methods, approaches, Bachelor’s/Master’s degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or other relevant fields.
Experience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research programs. Have critical and analytical thinking, and communication skills.
Master’s Minimum 2
Bachelor’s Minimum 6 summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
Analyst IV
As an expert, uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided. With minimal direction from project leaders, performs complex tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor’s /Master’s degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or other relevant field.
May be expected to have an advanced degree in area of specialty. E xperience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research programs.
5 Years
9 Years
Analyst V
Demonstrates a mastery of analysis and requirements engineering techniques and having experience leading a team as requirements engineer and uses relevant analytical and methodological tools needed to organize, perform, and deliver the services being provided.
performs tasks, including collection of quantitative and qualitative data from public sources, experts, and other sources, analysis and assessment of qualitative and quantitative data, writing of methods, approaches, summaries, evaluations and results, research on relevant topics to support the services being provided, and presentations for the relevant set of services.
Master’s degree in business administration, public policy, public health, health science, economics, communications, information technology, accounting, biology, chemistry, microbiology, physics, statistics, botanicals or other relevant field. Experience in biopharmaceutical manufacturing, quality analytics, biotechnology research and development or other area relevant research programs.
8 Years
Application Developer /Programmer –
I
Entry level developer, responsibilities are to create simple, single-thread code to achieve a specific task, assist the development team with all aspects of software design and coding. analyzes functional business applications and design specifications for functional areas Develops block diagrams and logic flowcharts. Translates detailed design into computer software, tests, debugs, and refines the computer software to produce the required product. Prepares required documentation, including both program- level and user-level documentation. knows different types of coding languages.
In general, work complexity and levels
High School, Associate degree, Bachelor's degree
Entry level developer, to write basic code, test code, and fix bugs.
High School Minimum 2-
Associate Minimum 1 years
0-1 Year
Application Developer/ Programmer
II
Advanced beginner application developer, Analyzes functional business applications and design specifications for functional areas Develops block diagrams and logic flowcharts.
Translates detailed design into computer software, tests, debugs, and refines the computer software to produce the required product. Prepares required documentation, including both program-level and user-level documentation.
knows different types of coding languages. An app developer is a computer software engineer whose primary responsibilities include assisting in design, development, implementation, and analysis of technical products and systems. Performs simple and routine engineering design tasks with standard techniques. creating, testing, and programming apps for computers, mobile phones, and tablets. These developers typically work in teams and think of ideas and concepts either for the general public, or for a specific customer need.
In general, work complexity and with knowledge of some high-level languages.
3 Years
2 Years
Application Developer /Programmer - III
(Application Engineer
III)
Relatively experienced and has excellent knowledge of at least one programming language. Analyzes functional business applications and design specifications for functional areas Develops block diagrams and logic flowcharts. Translates detailed design into computer software, tests, debugs, and refines the computer software to produce the required product. Prepares required documentation, including both program- level and user-level documentation. Knows different types of coding languages. Enhances software to reduce operating time or improve efficiency and may provide technical direction to others as required to ensure program deadlines are met.
In general, work complexity and with extensive knowledge in high or low-level languages.
excellent knowledge of at least one programming language
Minimum 8
Minimum 3
Programmer - IV -
(Application Engineer
IV)
Excellent knowledge of programming languages. Demonstrates the ability to perform programming tasks and large engineering projects with independence and expertise. Analyzes functional business applications and design specifications for functional areas Develops block diagrams and logic flowcharts. Translates detailed design into computer software, tests, debugs, and refines the computer software to produce the required product. Prepares required documentation, including both program-level and user-level documentation. Enhances software to reduce operating time or improve efficiency and may provide technical direction to others as required to ensure program deadlines are met.
In general, work complexity and
A Bachelor’s / Master's degree in Information Technology or a similar field, previous work experience and various certifications are typically required for this upper level position.
Knowledge in one of the following languages:
Machine Languages, Assembly languages, High-level Languages and System languages.
Programmer – V
(Application Engineer V)
Expert Knowledge. Typically senior staff engineer or advanced staff engineer.
Responsible for the overall system design. Documents development requirements for database, applications, and operation system environment.
Consults with end users to test and debug applications to meet client needs.
Serves as expert in all aspects of designing and application development.
May conduct training to IT Staff.
Demonstrates expertise in a variety of the field’s concepts, practices, and procedures. May provide consultation on complex projects and is considered to be a top-level contributor/specialist.
Bachelor/ Master’s degree in Information Technology or a similar field, previous work experience and various certifications are typically required for this upper-level position.
expertise in a variety of the field’s concepts, practices, and procedures
9 Years
6 Years
Biomedical Informatics
Specialist I
Identifies and resolves highly complex problems related to hardware and software, evaluate new biometric information technologies, prepare technical documentation, maintain an up-to-date knowledge of technology trends, plan and coordinate biometric user training, and may lead other IT support staff. Uses data to help clinicians, researchers and scientists improve human health and provide healthcare. Works under general supervision, with moderate latitude for the use of initiative and independent judgment.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor/ Master’s degree Experience in areas such as biomedical or scientific informatics, terminology, and related systems design and approaches.
Bachelor’s
Years
Biomedical Informatics Specialist II
Performs relatively complex health informatics work Uses data to help clinicians, researchers and scientists improve human health and provide healthcare. May develop training curriculum and conduct formal training sessions on the health information systems.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor/ Master’s degree Experience in areas such as biomedical or scientific informatics, terminology, and related systems design and approaches.
Bachelor’s Minimum 4
Specialist III
Performs complex health informatics work.
Augments or directs teams providing high level biomedical functional systems analysis, design, integration, documentation. Serves as project lead and senior specialist for content domain areas and/or development projects, including liaison duties with stakeholders and subject matter experts.
In general, work complexity and
Progressive experience in areas such as biomedical or scientific informatics, terminology, and related systems design and approaches. Must have a Master’s degree.
For major, select assignments a MD, PhD, or other advanced degree with commensurate special experience, plus a minimum of three
(3) years additional experience in biomedical information systems content design and management, including thorough knowledge of major biomedical terminology standard products and terminology development practices, is required.
PhD
Specialist IV
Augments or directs teams providing high level biomedical functional systems analysis, design workflows. Measuring impact, integration, documentation.
Serves as project lead and senior specialist for content domain areas and/or development projects, including liaison duties with stakeholders and subject matter experts.
In general, work complexity and responsibility will be greater at higher levels.
Highly progressive experience in areas such as biomedical or scientific informatics, terminology, and related systems design and approaches. Must have a Master’s degree.
For major, select assignments a MD, PhD, or other advanced degree with commensurate special experience, plus a minimum of three
(3) years additional experience in biomedical information systems content design and management, including thorough knowledge of major biomedical terminology standard products and terminology development practices, is required.
Master’s
7 Years
Specialist V
Directs teams providing high level biomedical functional systems analysis, design, integration, documentation.
Serves as project lead and senior specialist for content domain areas and/or development projects, including liaison duties with stakeholders and subject matter experts.
Expert knowledge in areas such as biomedical or scientific informatics, terminology, and related systems design and approaches. Must have a PhD. For major, select assignments a
MD, PhD, or other advanced degree with commensurate special experience, plus a minimum of three (3) years additional experience in biomedical information systems content design and management, including thorough knowledge of major biomedical terminology standard products and terminology development practices, is required.
MD/PhD
Bioinformatician I
Collect, manage, and study biological (especially DNA) and biochemical data at the molecular level by using computer software and hardware. Design computer databases and develop complicated mathematical formulas called algorithms to study and manage data.
In general, work complexity and responsibility will be greater at higher
Having the ability and experience with using computational tools, developing, and using mathematical models and statistical analysis to gather and analyze data in the field, such as genetics, biology, and pharmaceutical development. ability to learn, and use, complex technology.
Bachelor’s
0 - 1
Bioinformatician II
Provide high level expertise in the application of information technology to biological, biomedical, and population research. Use computational tools to gather and analyze data in fields including but not limited to genomics, epidemiology, clinical trials, and imaging, using methods such as statistics, mathematics, advanced visualization, simulations, and/or machine learning.
Provide expertise across a wide variety of informatics and data science areas as applied to discovery biology, clinical decision support, and public health.
Provide expertise in the integration of a variety of heterogeneous biomedical information systems and databases and support the sharing and dissemination of this information.
In general, work complexity and responsibility will be greater at higher
Progressively responsible experience in the individual’s field of study and specialization and Master’s degree required in the specific subject matter. A Bachelor’s degree in biology/computer science/engineering plus four (4) years of additional directly related work experience over and above the minimum experience requirements for this position may be substituted for the Master’s degree.
Develop and use mathematical models and statistical analysis for more complex projects
Bachelor’s Minimum
Bioinformatician III
Provide high level expertise in the application of information technology to biological, biomedical, and population research. Use computational tools to gather and analyze data in fields including but not limited to genomics, epidemiology, clinical trials, and imaging, using methods such as statistics, mathematics, advanced visualization, simulations, and/or machine learning.
Provide expertise across a wide variety of informatics and data science areas as applied to discovery biology, clinical decision support, and public health.
Provide expertise in the integration of a variety of heterogeneous biomedical information systems and databases and support the sharing and dissemination of this information.
In general, work complexity and responsibility will be greater at higher
Master’s/PhD and doctorate- level degree required in the specific subject matter. A Master’s degree in biology/computer science/engineering plus six
(4) years of additional directly related work experience over and above the minimum experience requirements for this position may be substituted for the doctorate degree.
Bioinformatician IV
Leads large and complex research programs to mine and unstructured biological datasets using computer programming or advanced statistical methods the application of information technology to biological, biomedical, and population research. Commitment to solving biological problems and communicating these solutions and ability to multi-task across projects Use computational tools to gather and and doctorate- level degree required in the specific subject matter. A Master’s degree in biology/computer science/engineering plus six
(6) years of additional directly related work experience over and above the minimum experience requirements for this position may be substituted for the doctorate degree and
PhD analyze data in fields including but not limited to genomics, epidemiology, clinical trials, and imaging, using methods such as statistics, mathematics, advanced visualization, simulations, and/or machine learning. Provide expertise across a wide variety of informatics and data science areas as applied to discovery biology, clinical decision support, and public health.
Provide expertise in the integration of a variety of heterogeneous biomedical information systems and databases and support the sharing and dissemination of this information.
programming expertise.
Bioinformatician V
Manages/Directs the application of information technology to biological, biomedical, and population research.
Use computational tools to gather and analyze data in fields including but not limited to genomics, epidemiology, clinical trials, and imaging, using methods such as statistics, mathematics, advanced visualization, simulations, and/or machine learning. Provide expertise across a wide variety of informatics and data science areas as applied to discovery biology, clinical decision support, and public health.
responsible for managing large databases, developing data frameworks, and creating and modifying algorithms
Provide expertise in the integration of a variety of heterogeneous biomedical information systems and databases and support the sharing and dissemination of this information.
and doctorate- level degree required in the specific subject matter. A Master’s degree in biology/computer science/engineering plus six
(6) years of additional directly related work experience over and above the minimum experience requirements for this position may be substituted for the doctorate degree. And expert knowledge in programming and data proficiency in creating and integrating databases.
PhD
4 Years
10 Years
Bioinformatics
Contributes to scientific analysis of data generated by multiple research projects using a variety of software applications.
Their responsibilities include, but are not limited to, data analysis, data harmonization, results presentation, script writing, and outreach.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor's degree and experience in a field or related area.
Specialized skills include experience with requirements definition and analysis, user acceptance testing, and documentation of systems used in the capture or standardization of health information, clinical information, or other data related to therapeutic discovery, medical research, or life sciences.
1 year
Bioinformatics Analyst
II
Responsible for providing stakeholder management, requirements gathering, information modeling, process documentation, and liaison tasks required to support the development of clinical informatics software or other clinical informatics project activities.
Works independently or under general direction, as well as in a client-facing manner for requirements capture.
In general, work complexity and
Bachelor’s degree experience in a field or related area, of which at least six (6) must be specialized. Specialized skills include experience with requirements definition and analysis, user acceptance testing, and documentation of systems used in the capture or standardization of health information, clinical information, or other data related to therapeutic discovery, medical research, or life sciences.
specialized
III
The Senior Bioinformatics Analyst provides expert oversight in the areas of Healthcare Integration Standards, Standards Implementation, Data Integration, Systems Integration, Data Modeling, and Data Warehousing. The Senior HIM consultant additionally performs high-level analytical duties and serves as a liaison/advisor between the architecture and analysis team and standards bodies such as HL7. The individual provides leadership and training in the area of health standards.
In general, work complexity and
Bachelor’s Degree and experience in analysis and/or management experience in one or more of the disciplines associated with health sciences.
IV
Manages mission-critical tasks and projects across biomedical and information technology functional areas. Provides leadership for other staff and resolves issues and problems in fast paced technology challenging environments. Has expert clinical domain knowledge is specialty field as well as across biomedical and/or health information systems and informatics.
Manages, controls, and directs the activities of multiple program and project/task managers with overall responsibility for the implementation of health information system project phases. Directs and supports mission requirements definition, design, development, testing, verification and validation, documentation, and implementation biomedical applications.
In general, work complexity and
Doctoral-level degree (MD or PhD) with experience in one or more of the disciplines associated with the health sciences.
MD/PhD
V
Manages mission-critical tasks and projects across biomedical and information technology functional areas. Provides leadership for other staff and resolves issues and problems in fast paced technology challenging environments. Has expert clinical domain knowledge is specialty field as well as across biomedical and/or health information systems and informatics.
Manages, controls, and directs the activities of multiple program and project/task managers with overall responsibility for the implementation of health information system project phases. Directs and supports mission requirements definition, design, development, testing, verification and validation, documentation, and implementation biomedical applications.
Doctoral-level degree (MD or PhD) with experience in one or more of the disciplines associated with the health sciences.
Business Process
Collects, monitors, and analyzes process metrics to identify trends and opportunities for potential improvement.
Designs and executes business process improvement studies, including collecting and analyzing relevant data, researching best practices and relevant benchmarks, analyzing costs and benefits of alternatives, and formulating and presenting recommendations.
Assists management in implementing process improvements and developing implementation plans.
In general, work complexity and with experience with communication and presentation skills.
1 Years
Analyst II
Collects, monitors, and analyzes process metrics to identify trends and opportunities for potential improvement.
Designs and executes business process improvement studies, including collecting and analyzing relevant data, researching best practices and relevant benchmarks, analyzing costs and benefits of alternatives, and formulating and presenting recommendations.
Assists management in implementing process improvements and developing implementation plans.
In general, work complexity and and experience with excellent communication and presentation skills focused on tailoring information to meet the needs of different stakeholders.
Analyst III opportunities for potential improvement.
Designs and executes business process improvement studies, including collecting and analyzing relevant data, researching best practices and relevant benchmarks, analyzing costs and benefits of alternatives, and formulating and presenting recommendations.
Assists management in implementing process improvements and developing implementation plans.
In general, work complexity and experience with excellent communication and presentation skills focused on tailoring information to meet the needs of different stakeholders.
Analyst IV opportunities for potential improvement.
Designs and executes business process improvement studies, including collecting and analyzing relevant data, researching best practices and relevant benchmarks, analyzing costs and benefits of alternatives, and formulating and presenting recommendations.
Assists management in implementing process improvements and developing implementation plans.
In general, work complexity and and a minimum of 8 years of experience with excellent communication and presentation skills focus on tailoring information to meet the needs of different stakeholders.
Certified by one of institutions that exist e.g.
Certified Business Analysis Professional (CBAP)
Analyst V
Responsible for defining and developing business processes, policies, roles and responsibilities, and performance metrics. Conducts analysis of business processes: current state analysis, gap analysis, benchmarking, best practices identification, organizational assessment, and other related tasks. Takes project from original concept through final implementation. May coordinate with business and technology teams, ascertaining system requirements, such as program functions, output requirements, input data acquisition, and system techniques and controls.
Plans and implements process improvements, including future state design, change management, and transition planning.
Conduct client interviews. May deliver and a minimum of 15 years of experience within the scope of the contract.
Certification by one of the institutions that exist e.g.
Certified Business
Analysis Professional (CBAP) presentations and training courses including measurement, analysis, improvement, and control. May perform cost and benefit analysis. Interfaces with all areas of project including customer, computer services, and client services.
Responsible for business process consulting activities in an assigned region or vertical, including staffing and project oversight. Works on complex tasks where analysis of client's data requires an evaluation of identifiable factors. May serve as project lead for large or complex projects. Develops, standardizes, and customizes process methodologies.
Clinical Information / Data Analyst- Senior
Utilizes and applies analysis tools such as statistical software, natural language processing software and other quantitative and qualitative data analytic computer applications to various databases of information. Assists in recommending and prioritizing system enhancements that support client/user satisfaction and system adoption.
Participates in creation of specifications and testing of data collection systems and data warehouses. Ensure and optimize integration of system with other internal systems and business unit workflows. Provides technical support for report development and data analysis.
undertake quality improvement initiatives and give departmental orientations.
Degree or postgraduate degree in Statistics, Mathematics, Economics, Operational research, or Psychology.
At least ten years of experience required.
Minimum
Clinical Trials Coordinator I
Provides rigorous clinical study support to client’s study participants. The primary role of the Clinical Operations Specialist is to support study participants in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). Study participant support over phone and email through inbound and outbound activity.
Participant enrollment and consent verification. Technical troubleshooting for devices and gather feedback from participants.
In general, work complexity and
Bachelor’s Degree.
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical
Practice (GCP). Experience supporting clinical study operations and interacting with study participants.
0 Years
Clinical Trials Coordinator II
Provides rigorous clinical study support to client’s study participants. Works under clinical research managers and are tasked with administering clinical trials.
Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor’s Degree.
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP). Experience supporting clinical study operations and interacting with study participants.
Year1
Clinical Trials Coordinator III
May Lead rigorous clinical study support to client’s study participants. Works under clinical research managers and are tasked with administering clinical trials.
Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor’s Degree.
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP). Experience supporting clinical study operations and interacting with study participants.
Minimum 3 Years
Clinical Trials Coordinator IV
Leads rigorous clinical study support to client’s study participants. Works under clinical research managers and are tasked with administering clinical trials.
Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
In general, work complexity and responsibility will be greater at higher levels.
Bachelor’s Master’s degree Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP). Experience supporting clinical study operations and interacting with study participants.
Bachelor’s Minimum
Years
Clinical Trials Coordinator V
Manages/Directs rigorous clinical study support to client’s study participants.
Works under clinical research managers and are tasked with administering clinical trials. Their primary responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
Bachelor’s /Master’s degree.
Knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP). Experience supporting clinical study operations and interacting with study participants.
Bachelor’s Minimum 18
Assists with data loading, Extraction, Transformation, and Load. Assists in the preparation of simple, routine report
Data Analyst - I generation and analysis. Prepares analysis reports. Learns to analyze data sets for trends links, patterns, and anomalies.
May serve as a junior database administrator as collateral duty. May include data backup and restore duties.
Data analysts typically work with existing data to solve defined business problems.
Data scientists build new algorithms and models to make predictions about the future.
In general, work complexity and responsibility will be greater at higher levels
High School/Associate/BS degree in Mathematics, Economics, Computer
Science, Information Management or Statistics.
Experience in field or related area.
Associate
0 – 1 Years
Data Analyst - II
Assists with data loading, Extraction, Transformation, and Load. Assists in the preparation of simple, routine report generation and analysis. Prepares analysis reports. Learns to analyze data sets for trends links, patterns, and anomalies.
May serve as a junior database administrator as collateral duty. May include data backup and restore duties.
Data analysts typically work with existing data to solve defined business problems.
Data scientists build new algorithms and models to make predictions about the future.
In general, work complexity and
High School/Associate/Bachelor’s degree in Mathematics, Economics, Computer
Science, Information Management or Statistics.
Experience in field or related area.
High School
Data Analyst - III
Duties may include data loading, Extraction, Transformation, and Load (ETL). Contributes to moderately complex aspects of a project. Prepares data reports and analyze trends, links, patterns, and anomalies. May serve as a database administrator as collateral duty. May include preparation of data visualization and analysis presentations to customer. work is generally independent and collaborative in nature.
Supports day-to-day project operations and performs assigned tasks. Strong knowledge of SQL, or Structured Query Language, Microsoft Excel. R or Python–Statistical Programming. Data Visualization, Presentation Skills and Machine Learning.
In general, work complexity and in Mathematics, Economics, Computer
Science, Information Management or Statistics.
Experience in field or related area.
Minimum 5
Data Analyst - IV
Responsible for providing leadership to junior and mid-level analysts. Provides analytic and technical skills necessary to innovate, build, and maintain well-managed data solutions and capabilities to solve business problems. Conducts detailed data analysis on data used across business units to evaluate business processes and improves on/creates new feature.
Provides relational database expertise to construct and executes queries to be used in data analysis activities. Provides expertise and translates the business needs to design; and develop tools, techniques, and metrics, and dashboards for insights and data visualization. transform data into usable metrics.
Responsible for providing leadership to junior analysts. Expert knowledge of SQL, or Structured Query Language, Microsoft Excel. R or Python–Statistical Programming. Data Visualization, Presentation Skills and Machine Learning.
In general, work complexity and
Master’s degree in Analytics, Computer Science, or Data
Science; Mathematics or in a related field.
Experience in data analysis using any of these languages SQL or Structured Query Language, Microsoft Excel. R or Python–
Statistical Programming. Data Visualization, Presentation Skills and Machine Learning.
Data Analyst -V
Possesses mastery knowledge of applying analytic methodologies and principles to address project needs.
Serves as a member of the project team performing analytical tasks and technical team assignments; performs research, support, and reporting functions. More specifically, the Senior Data Analyst has working knowledge of software packages including one or more of the following:
SAS, SQL, Business Objects, MS Excel, and MS Access. Fluency in SAS is essential. Responsible for providing leadership to junior and mid-level analysts. Provides analytic and technical skills necessary to innovate, build, and maintain well-managed data solutions and capabilities to solve business problems.
Conducts detailed data analysis on data used across business units to evaluate business processes and improves on/creates new features. Provides relational database expertise to construct and execute queries to be used in data analysis activities.
Master’s/PhD degree in Computer Science, Information Systems, Engineering, Business, or other related scientific or technical discipline.
Expert knowledge in SAS.
Provides expertise and translates the business needs to design; and develop tools, techniques, and metrics, and dashboards for insights and data visualization.
Responsible for providing leadership to junior analysts. Strong knowledge of SQL, or Structured Query Language, Microsoft Excel. R or Python–Statistical Programming. Data Visualization, Presentation Skills and Machine Learning. this data analyst is also in a managerial role
Data Architect I
Designs and builds relational databases for data storage or processing. Develops strategies for warehouse implementation, data acquisition, and archive recovery.
Cleans and maintains the database by removing and deleting old data. May evaluate new data sources for adherence to the organization’s quality standards and ease of integration. May lead and direct the work of others.
In general, work complexity and in Computer Science, Computer Engineering, or a related field. Strong written and verbal communication skills.
Associate Minimum
Data Architect II
Responsible for visualizing and designing an organization's enterprise data management framework. This framework describes the processes used to plan, specify, enable, create, acquire, maintain, use, archive, retrieve, control, and purge data. good understanding of the cloud, databases in general, and the applications and programs. Design models of data processing that implement the intended business model.
Develop diagrams representing key data entities and their relationships.
In general, work complexity and
Associate/Bachelor’s degree either Computer Science, Computer Engineering, or a related field. Strong written and verbal communication
Masters
Data Architect III
Responsible for visualizing and designing an organization's enterprise data management framework. This framework describes the processes used to plan, specify, enable, create, acquire, maintain, use, archive, retrieve, control, and purge data. good understanding of the cloud, databases in general, and the applications and programs. Design models of data processing that implement the intended business model.
Develop diagrams representing key data entities and their relationships.
In general, work complexity and
Associate/Bachelor’s/ Master's degrees and requisite experience. Knowledge of a variety of programming languages and advanced technologies associated with big data, AI, IoT and the cloud.
Certified Solutions Architect
Data Architect IV
Highly experienced. Responsible for visualizing and designing an organization's enterprise data management framework.
This framework describes the processes used to plan, specify, enable, create, acquire, maintain, use, archive, retrieve, control, and purge data. good understanding of the cloud, databases in general, and the applications and programs.
Design models of data processing that implement the intended business model.
Develop diagrams representing key data entities and their relationships.
In general, work complexity and
Bachelor’s/ Master's degrees.
Highly experienced with using a variety of programming languages and advanced technologies associated with big data, AI, IoT and the cloud.
Cloud Certified Solutions Architect
Data Architect V
Expert Knowledge - Responsible for visualizing and designing an organization's enterprise data management framework.
This framework describes the processes used to plan, specify, enable, create, acquire, maintain, use, archive, retrieve, control, and purge data. good understanding of the cloud, databases in general, and the applications and programs.
Design models of data processing that implement the intended business model.
Develop diagrams representing key data entities and their relationships.
Bachelor’s/ Master's degrees.
Expert experience using a variety of programming languages and advanced technologies associated with big data, AI, IoT and the cloud.
Cloud Certified Solutions Architect
12 Years
Data Entry Specialist I
The Data Entry Specialist performs data entry in software programs. Responsible for meeting accuracy requirements and turn-around times. Tests customer and account system changes and upgrades by inputting new data and reviewing output. Secures information by completing database backups and securing source data when not in use.
Follows policies and procedures.
Prepares source data for entry by opening and sorting mail; verifying and logging receipt of data; obtaining missing data.
In general, work complexity and
High School diploma or GED certificate.
Ability to type a minimum of 40 WPM with a working knowledge of word-processing and database technologies.
0 - 1 Years
Data Entry Specialist II
The Data Entry Specialist performs data entry in software programs. Responsible for meeting accuracy requirements and turn-around times. Tests customer and account system changes and upgrades by inputting new data and reviewing output. Secures information by completing database backups and securing source data when not in use.
Follows policies and procedures.
Prepares source data for entry by opening and sorting mail; verifying and logging receipt of data; obtaining missing data.
In general, work complexity and responsibility will be greater at higher levels.
High School diploma or GED certificate.
Ability to type a minimum of 40 WPM with a working knowledge of word-processing and database technologies, experience using databases and spreadsheets.
2 – 4 Years
Data Entry Specialist III entry in software programs. Responsible for meeting accuracy requirements and turn-around times. Tests customer and account system changes and upgrades by inputting new data and reviewing output. Secures information by completing database backups and securing source data when not in use.
Follows policies and procedures.
Prepares source data for entry by opening and sorting mail; verifying and logging receipt of data; obtaining missing data.
In general, work complexity and
High School diploma or GED certificate.
Ability to type a minimum of 40 WPM with a working knowledge of word-processing and database technologies experience using databases and spreadsheets.
Data Entry Specialist
The Data Entry Specialist performs data entry in software programs. Responsible for meeting accuracy requirements and turn-around times. Tests customer and account system changes and upgrades by inputting new data and reviewing output. Secures information by completing database backups and securing source data when not in use.
Follows policies and procedures.
Prepares source data for entry by opening and sorting mail; verifying and logging receipt of data; obtaining missing data.
In general, work complexity and
High School diploma or GED certificate/Associate Degree
Ability to type a minimum of 40 WPM with a working knowledge of word-processing and database technologies experience using databases and spreadsheets.
High School
6 Year
Data Entry Specialist V entry in software programs. Responsible for meeting accuracy requirements and turn-around times. Tests customer and account system changes and upgrades by inputting new data and reviewing output. Secures information by completing database backups and securing source data when not in use.
Follows policies and procedures.
Prepares source data for entry by opening and sorting mail; verifying and logging receipt of data; obtaining missing data.
In general, work complexity and
High School diploma or GED certificate/Associate Degree.
Ability to type a minimum of 40 WPM with a working knowledge of word-processing and database…
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