15-223-SOL-00185_Atch_9_Labor_Categories_and_Descriptions.pdf

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Electronic Laboratory Notebook Federal contract opportunity
Solicitation number
15-223-SOL-00185
Issued by
Department of Health and Human Services Food and Drug Administration

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Labor Categories Descriptions

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15-223-SOL-00185 Atch 9 Labor Categories and Descriptions

1. Program Manager

Serves as Program Manager for a large, complex program with centralized and task orders support requirements. Manages substantial contract support operations including multiple projects. Organizes, directs, and coordinates planning and production of all support activities for the program. Has demonstrated experienAce for oral and written communications with all levels of management for planning and control of projects. Is able to interface with the client’s management personnel, clients contracts staff, and other officials. Is capable of meeting in conference with clients project managers and state problems in a form capable of being solved. Formulates and reviews project plans, determines cost, and ensures conformance to work standards. Is responsible for formulating and enforcing work standards, assigning contractor schedules, reviewing work discrepancies, supervising contractor personnel and communicating policies, purposes, and goals of the organization to subordinate.

2. Project Manager

Responsible for the oversight and primary management of project s including the day to day responsibility for successful engagement. Directs completion of tasks within estimated timeframes and budget constraints. Schedules and assigns duties to subordinates and subcontractors and ensures assignments are competed as directed. Ensures compliance with contract requirements Has significant technical and functional expertise in relevant methodologies utilized within the projects.

3. COTS Tool SME / Technical Support

Demonstrates experience in architecting and planning implementation of the selected Electronic Laboratory Notebook (ELN) Software Solution. Collects requirements from stakeholders, participates in change management, and identifies business process workflows for offices / laboratories. Utilize special skills in premium technologies such as enterprise software tools and methodologies. Utilize extensive experience in planning and managing large scale, complex projects including controlling change control, scheduling, performance, budgets, and overall project scope. Set overall application policy direction for client engagements; communicate with client executive management to ensure critical issues are addressed in application architecture; provide expert guidance to application implementation projects in industry, technical and functional areas; and oversee contract and financial management.

4. Junior Scientist

Provide recommendations to scientists that conduct moderately complex experiments on how to effectively and efficiently conduct research using the selected ELN software product. Assists with presenting data to external groups. Understands study protocols and reports covering several lines of experimentation. Assists with writing reports covering data and non-data project topics. Capable of operating complex lab equipment and performing routine maintenance/repair. Assists in the establishment of procedures and research methodologies utilized using the selected ELN tool. Provides recommendations and observations to scientific staff. Initiates literature review and searches. Trains others on ELN software solution and serves as a resource for solving product issues.

5. Mid-Level Scientist

Provides recommendations and guidance to FDA scientists on writing reports that synthesize experimental results into a working hypothesis and details future plans using the ELN solution. Assist the scientist conduct detailed data analysis and interpretation utilizing the selected ELN solution. Establish and implement SOPs for using the ELN solution.

6. Subject Matter Expert / Master Scientist

Develop, modify, and implement bioinformatics workflows and pipelines for genomic analysis of bacteria and specimens. Provide support to FDA team members involving bioinformatics methods and interpretation of genomic analyses

7. Business Analyst

Applies process improvement and reengineering methodologies and principles to conduct process modernization technology projects. Responsible for effective transitioning of existing project teams and the facilitation of project teams in the accomplishment of technical project activities and objectives.

Provides group facilitation, interviewing, training, and provides additional forms of knowledge transfer.

Key coordinator between multiple project teams to ensure enterprise-wide integration of reengineering and technical efforts.

8. IT Architect

Works independently under general guidance. Fully knowledgeable in all aspects of program, technical or functional area. Manages multiple systems acquisition program/project of major technical or functional areas. Coordinates and establishes policies, architectures, inter-relationships between multiple and related technologies and or programs within an Enterprise. Establishes objectives and requirements, develops program budgets, standards, and schedules for multiple projects/programs.

Monitors outside resources with experience or extensive knowledge with the processes and procedures related to the technical and functional areas. Coordinates, reviews, and supervises work of assigned staff. Provide knowledge transfer and mentoring as appropriate. Orient and train consulting staff.

Demonstrates highly developed written, technical, interpersonal communication, and conflict resolution skills.

9. Network Engineer

Develops technical designs and specifications for software products, components and subsystems.

Designs, develops, tests, evaluate, and debug code for software components that meet product specification and development schedules. Provides technical leadership to the team.

10. Documentation Specialist / Writer

Prepares and edits technical documentation including software and system documentation, and other technical publications. Applies knowledge of required standards and verifies that documentation conforms to standards. Conducts technical research and collaborates with technical professionals.

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