Task_Order_for_Technical_Proposals.pdf

Performance Work Statement (PWS) for Program Management, Administrative, and Logistic Support

INTRODUCTION

This requirement shall provide Program Management, Administrative, and Logistic Support services to the U.S. Naval Medical Research Unit (NAMRU) INDO PACIFIC in the conduct of biomedical, epidemiological, and clinical research, including human subject and animal use research program. The Contractor shall provide program management, administrative, and logistic support facilitating Navy Medicine’s mission to conduct Research & Development (R&D) across its enterprise, including commands that the Navy collaborates with, supports, and reports to (e.g., OASD-Health Affairs, Defense Health Agency, US Army). In addition to providing personnel, materials, equipment, and facilities (non-construction (bonded), non- Government spaces), efforts shall address process infrastructure (such as basic research, biosurveillance, vaccine development, clinical trials, outbreak response, or FDA IND application processing) and market research on topics such as new field sites and in-country resources.

BACKGROUND

NAMRU INDO PACIFIC, based in Singapore, is at the forefront of the U.S. Department of Defense’s disease surveillance efforts in the Indo-Pacific Command (INDOPACOM) Area of Responsibility (AOR). Within the context of its ongoing disease surveillance activities, NAMRU INDO PACIFIC is well positioned to evaluate novel diagnostics products and therapeutic interventions, test disease control strategies, and to develop local expertise via training to detect and respond to emergent disease threats. In consonance with its mission, the NAMRU INDO PACIFIC requires contractor support for overall program management, administration, and logistic support across the INDO PACIFIC AOR.

Highly trained Navy Medicine personnel deploy with Sailors and Marines worldwide providing critical mission support aboard ship, in the air, and on the battlefield. At the same time, Navy Medicine’s military and civilian health care professionals are providing care for uniformed services’ family members and retirees at military treatment facilities around the globe.

NAMRU INDO PACIFIC performs ongoing disease surveillance to provide up-to-date Force Health Protection Guidance to U.S. Military personnel.

SCOPE

This task order shall provide program management, administrative, and logistic support to NAMRU INDO PACIFIC in the conduct of biomedical, epidemiological, and clinical research efforts.

Direct position program support includes the following: Project: Position Support Management Services Locations: United States, Malaysia, Vietnam Additional sites in the Indo-Pacific region (e.g., Lao PDR) may be required.

ANTICIPATED LEVEL OF EFFORT (LOE)

The Government estimates the LOE in the specified countries as outlined in the Table below.

Services required

No. of hours (1.0 FTE = 1912 hrs.)

Program Manager (U.S. based) 1912

Project Associate (U.S.) 956 Regional Program Manager (Kuala Lumpur, Malaysia)

Project Associate (Vietnam) 1912

Senior Epidemiologist/Analyst (Remote – Indo-Pacific region)

Entomologist (Malaysia) 956 Data Manager (Kuala Lumpur, Malaysia) 1912

UNITED STATES LEVEL OF EFFORT

The descriptions and qualifications of the positions to be filled are listed below.

Program Manager (PM) – (1.0 FTE at 1,912 hours per FTE) (Key Personnel)

a. Description: The PM shall provide overall administrative and management oversight of contractors and if applicable, subcontractors, in order to maximize the effective use of program resources. The PM shall coordinate corporate support for research program functions and activities with NAMRU INDO PACIFIC leadership, Regional Program Manager (RPM), and Project Associates (PAs). The PM shall provide recommendations to NAMRU INDO PACIFIC leadership for defining and determining personnel, budgets, and facilitating the establishment of agreements with in-country collaborators and subcontractors to initiate foreign research projects.

b. Qualifications: This position requires the equivalent of a college degree in Human Resources

Management, Business Administration, or science-related field plus at least 3 years’ experience in supporting US military medical R&D programs. Equivalent of an advanced degree is preferred but not required. PMP certification is preferred. Proficiency in written and oral English is required.

Project Associate (PA-US) - (0.5 FTE, 956 hours)

a. Description: PA duties and related services include but are not limited to: developing and updating template to input updates for monthly reports; managing subcontractors in terms of tracking deliverables, ensuring subcontractors have met all required institutional review board (IRB) requirements and maintain up-to-date IRBs on all projects; tracking burn rates;

obtaining translation services for documents as needed; following up on queries from the subcontractor related to public affairs processes; and preparing contractor, and possibly subcontractor, travel authorization requests, and invoicing. The PA shall report to the PM.

b. Qualifications: Bachelor’s degree in a related field with at least two years of related experience preferred; project management experience preferred; excellent written and oral communication skills; proven ability to effectively manage relationships (e.g., with internal actors, etc.); solid organizational skills; ability to be flexible and work well under pressure in a fast-paced multi-task team environment. Proficiency in written and oral English is required.

INDO-PACIFIC REGION LEVEL OF EFFORT

Regional Program Manager (RPM) - (1.0 FTE, 1,912 hours, based in Kuala Lumpur, Malaysia) (Key Personnel)

a. Description. The RPM shall assist the PM and provide supervision of Regional PAs. The

RPM shall interface successfully with NAMRU INDO PACIFIC partners to ensure programmatic progress is made. The candidate should have strong organizational skills, management skills, and problem-solving skills. The candidate should be able to travel within Malaysia and to regional countries to provide support and monitoring across all programs and act as a liaison to the customer.

b. Qualifications: Bachelor’s degree in a related field with at least three years of related experience; project management experience, supervisory experience preferred; excellent written and oral communication skills; proven ability to effectively manage relationships (e.g., with internal actors, etc.); familiarity with countries in the region preferred; solid organizational skills; ability to be flexible and work well under pressure in a fast-paced multi-task team environment; ability to travel to countries in the region. Proficiency in written and oral English and Bahasa Malaysia is required. Ability to translate documents from Bahasa Malaysia to English and vice versa is desired.

Project Associate (PA-VN) - (1.0 FTE at 1,912 hours, based in Vietnam)

a. Description: With guidance from PM and RPM, the PA-VN shall provide a range of administrative, operational/logistical and project management support in order to facilitate the effective achievement of program goals.

Specific tasks of the PA-VN shall include:

1. Participate in monthly and other meetings with NAMRU INDO PACIFIC partners, develop agenda to facilitate the discussion, take meeting minutes, update the project work plan and follow-up as needed to complete actions.

2. Establish strong working relationship with NAMRU INDO PACIFIC staff, contractors and partners, and act as the primary collector of information, requests, etc. that require technical review/approval.

3. Utilize existing calendar system to track milestone dates, travel of core program staff, major holidays and other items that impact the programs.

4. Prepare for and attend monthly check in call for the assigned sub-program projects. Each call should include key program staff with updates on the program timelines and deliverables.

5. Develop operational reports and coordinate with the US-based project associate to produce a consolidated operational report.

6. Perform outreach and communication with internal and external stakeholders both orally and in writing.

7. Facilitate equipment purchasing and shipment logistics.

b. Qualifications: Bachelor’s degree in a related field with at least two years of related experience; project management experience preferred; excellent written and oral communication skills; strong knowledge of Microsoft Office and Windows based computer applications; familiarity with countries in the region preferred; solid Administrative Assistant organizational skills; ability to be flexible and work well under pressure in a fast-paced multi-task team environment; ability to travel within Vietnam or to countries in the region. Proficiency in written and oral English and Vietnamese is required. Ability to translate documents from Vietnamese to English and vice versa is desired.

Senior Epidemiologist/Analyst - (0.5 FTE at 956 hours, based remotely in Indo-Pacific region)

a. Description: The senior epidemiologist/analyst shall provide statistical analysis, surveillance and protocol planning/design, and overall public health improvement to investigate diseases, pathogens of operational concern, or other public health concerns to determine burden, incidence, causes, risk factors, life cycles, and/or modes of transmissions with a focus on end products to remedy the public health concern.

Specific tasks of the Senior Epidemiologist/Analyst include, but are not limited to:

1. Provide recommendations of ways to prevent human and animal disease and treatments for disease.

2. Provide expertise in the design, management, and evaluation of study protocols and health status questionnaires, sample selection, and data analysis.

3. Provide expertise regarding outbreak investigations and response plans in collaboration with in-country research partners.

4. Maintains a familiarity with clinical and epidemiological practice guidelines, clinical research models, protocol designs, late-phase development trends, and regulatory expectations.

5. Conduct a priori power analyses, sample size calculations, real- time data analyses, and interpret bio-surveillance findings to assist in the development of conclusive research reports related to epidemiological studies.

6. Create statistical databases, statistical code, and variable description lists for datasets to build organizational capacity.

7. Provide analytic support in the development and maintenance of ongoing public health initiatives with colleagues and in-country partners.

8. Analyze research and statistical data knowing some data can be historical, analyzed in ways not previously anticipated, or contemporary, being acquired from completed research studies or clinical trials.

9. Assist in the drafting, reviewing, and editing of knowledge-based products (e.g., Peer reviewed publications, scientific notes, presentations, posters, etc.).

10. Assist NAMRU INDO PACIFIC staff and investigators with identifying funding opportunities and developing grant proposals.

b. Qualifications: Senior epidemiologist/analyst necessitates a doctoral degree (M.D. and/or

Ph.D.) in public health, epidemiology, biostatistics, biology, or a subfield of biology with strong statistical analysis skills, or another related field from an accredited college or university. Other experience in a relevant field includes but is not limited to management, analysis, or policy development. It is preferred the candidate have at least 4-6 years of experience in clinical and epidemiological research. Experience in building national public health programs in developing countries is a plus. A minimum of 3-4 years of previous international work experience, the ability to work both independently, and the ability to work on a team in an interdisciplinary environment are essential. Above average attention to detail, accuracy, and organizational skills are preferred. Must be a strong scientific writer, have excellent computer skills with Microsoft Excel, Access, PowerPoint, and Word, have knowledge of public health datasets, agencies, and programs such as the CDC and Census Bureau, have experience in grant writing and preparation of grant applications, be fluent in one or more of the following statistical programs: SAS, SPSS, Stata, R, and be familiar with various data mapping and visualization tools.

Entomologist - (0.5 FTE at 956 hours, based in Malaysia)

a. Description: The Entomologist shall provide entomological support such as identification of study locations and specimens collected, engagement with local community vector and health care personnel in locations identified as study locations as directed, to ensure specimen collections can be obtained from identified location. Assist with the planning and execution of arthropod surveillance, to include the teaching of surveillance techniques, labeling, and perseveration of specimens for both morphological and pathogen identification. Must be able to travel to conduct surveillance, host training symposiums and workshops, give scientific presentations, and receive additional training. Ability to travel within Malaysia and countries in the region. Proficiency in written and oral English and Bahasa Malaysia is required.

Ability to translate documents from Bahasa Malaysia to English and vice versa is desired.

b. Qualifications: This position requires the equivalent of a master’s degree in Entomology, or relevant medical-science related field plus 6-10 years of experience supporting medical research programs. A PhD in Entomology is preferred. Proficiency in research study design and execution. Ability to instruct regional vector control and medical health entities on arthropod vector identification and surveillance techniques. Ability to conduct insecticidal resistance studies utilizing known methods from Center for Disease Control and Prevention and World Health Organization.

Data Manager - (1.0 FTE at 1912 hours, based in Kuala Lumpur, Malaysia)

a. Description: The data manager shall provide data management in support of NAMRU INDO

PACIFIC research programs.

Specific tasks of the Data Manager include, but are not limited to:

1. Gathers, stores, controls and manages data collected by civilian and military partners according to US HIPAA regulations.

2. Collects, transfers, organizes, cleans, and de-identifies data sets.

3. Maintains data repositories and develops repositories and systems architecture for new studies.

4. Provides input to Methods and References section for manuscripts.

5. Creates Tables, figures, display items and other required statistical graphics for manuscripts.

6. Supports manuscript development and formatting for submission.

7. Supports conference poster development.

8. Works with statistician, epidemiologist, NAMRU INDO PACIFIC scientists, and other collaborators named in a protocol to create data sets that can be used for the proper analyses.

b. Qualifications: A minimum of a master’s degree in public health, epidemiology, biostatistics, biology, or a subfield of biology with strong data management skills, or another related field from an accredited college or university. It is preferred the candidate have at least 4-6 years of experience in data management of datasets from clinical and/or epidemiological research. Ability to work independently and on a team in an interdisciplinary environment is essential including both remote and in-person settings. Above average attention to detail, accuracy, and organizational skills are required. Must be a strong scientific writer, have excellent computer skills with Microsoft Excel, Access, PowerPoint, and Word, have knowledge of public health datasets, agencies, and programs such as the CDC and Census Bureau, be fluent in one or more of the following statistical programs: SAS, SPSS, Stata, R, and be familiar with various data mapping and visualization tools.

TYPE OF CONTRACT CONTEMPLATED:

The Government is considering a non-personal services firm fixed priced (FFP) contract for research. The Government shall not exercise any supervision or control over the contractor(s) performing the services herein. Sub-contractors shall be accountable solely to the Contractor who, in turn is responsible to the Government.

PLACE OF PERFORMANCE

The work to be performed shall be in the USA and Indo-Pacific region (e.g., Malaysia, Vietnam, Lao PDR).

PERIOD OF PERFORMANCE (POP): 1 Sep 2024 – 31 Aug 2025

Recognized holidays: The contractor is not required to work on U.S. Government Holidays and local Government holidays where the work is being performed.

TRAVEL

a. All travel will be in accordance with the Joint Travel Regulations (JTR).

b. Travel costs are estimated at a maximum of $50,000 for the 12-month POP. Travel is required to provide onsite oversight of projects to ensure smooth and ongoing operations.

c. Estimated travel costs must be approved by the contracting officer’s representative (COR) prior to incurring actual costs. No profit shall be added to actual travel costs.

d. The contractor shall submit to the COR an estimate for the total cost of travel, broken down by cost elements (airfare, transportation, etc.) supported by relevant and recent market research as soon as the travel is known. Preference is submitting these estimated expenses 30 days in advance of travel but no less than two weeks prior to the requested travel dates.

e. The Contractor shall ensure, unless extraordinary, unforeseen circumstances arise, that the actual travel costs will not exceed the approved Government estimate.

f. Travel approval must be processed in accordance with FAR Part 31.205-46 Travel Costs. Travel costs will be reimbursed at actual costs incurred.

g. The guiding principle is to travel responsibly. “Responsibly” means that the traveler exercises the same care in incurring expenses for Government travel that a prudent person would. Travelers are to travel the most prudent (cost effective) and efficient for the Government to satisfy their needs, not necessarily for the traveler’s convenience, preference or professional standing/rank. The number of contractor personnel required will be determined at the discretion of the technical point of contact.

h. Trip reports to include contacts made and summarizing overall observations and conclusions shall be provided to the COR within seven days of return from the trip.

OTHER DIRECT COSTS (ODCs) ODCs are estimated at a maximum of $30,000 for the 12-month POP and may cover expenses such as general supplies, shipping, publication fees, and logistic support for NAMRU INDO PACIFIC research- related events. All ODCs shall be examined for appropriateness and reasonableness. Prior to incurring an actual expense, the contractor shall submit to the COR an estimate for the ODC, supported by relevant and recent market research. Preference is that estimated expense are submitted 30 days in advance but no less than two weeks prior to the desired receipt of the service or supply. The combined total for Travel and ODC shall not exceed $80,000.

DELIVERABLES/REPORTS

All Reports are property of the U.S. Navy.

The contractor shall not release to the public any information regarding the medical research or resulting data without the approval of the COR. The approval process may include blanket approval for some types of information releases.

The contractor shall submit to the principal investigator for review and approval prior to public disclosure any written publications or public relations materials (including proposed public announcements, flyers, posters, audiovisual materials, newspaper, advertisements, or mailed advertisements) which are targeted primarily to the scope of contract services or policies and programs of the contractor.

The Contractor shall submit to the COR monthly reports (by the 10th working day of each month for a total of 12 reports). Reports shall be in English and include contract execution that details a summary of all activities related to the performance of the task order.

Report details:

1. Cover page that includes the contract number/task order number, report number, and date of reporting period (Report 1, August 1-31, year).

2. Risk Register that identifies the risk or issue at stake/risk rating, impact, Action/Updates, Frequency of Monitoring, and the Vendor’s POC who is in charge.

3. Noteworthy achievements or deficiencies.

4. The report shall detail (a) the Services Category and a report of the Monthly Activities by position for each task order as well as describe on-going and recurring tasks to facilitate contract achievements, (b) challenges experienced related to the execution of the project and risk mitigation solutions, (c) noteworthy meetings, (d) and travel reports as applicable.

5. Other relevant contract achievements include but are not limited to: (a) developing materials and standardized PMO tools such as scientific project planning schedule, developing templates for the scientists to streamline their work, tracking project risks, conduct project management and integration plans etc., and (b) provide support to NAMRU INDO PACIFIC science summit in terms of PMO training, providing program and project updates, and assisting with the logistics and administrative support.

6. Assist and improve the administration and management of products required in research business cycle (e.g., negotiate complex terms and conditions with subcontractors, facilitate meetings with partners on projects, proposal review process, sustainment work-plan templates, Focus Area Roadmaps, requests for proposals, detailed budget spreadsheets, annual reporting requirements and feedback, etc.)

7. Conduct monthly phone cons with the Commanding Officer, Science Director. Technical Director and COR as requested.

8. Provide research support services in accordance with the QASP.

9. Provide trip reports on all trips to the COR

QASP:

TASK/

DELIVERABLE

PERFOMANCE

STANDARD

PERFORMANCE INDICATOR/

ACCEPTABLE LEVEL OF

PERFORMANCE

METHOD OF

SURVEILLANCE

PERFORMANCE RATING

Compliance of products, services, documents.

Related deliverables and overall quality of work performance.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

Does not cause a delay in schedule;

Does not cause costs to increase Involves minimal effort to fix;

Does not affect overall contractor performance.

All matters shall be resolved in a satisfactory and timely manner.

Random inspection (by reviewing monthly report).

Are study reports complete and are they compliant with various government regulations?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements require re-performance/rework. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Timeliness of Performance and Services and Product Deliverables, including Administrative aspects of Performance

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

does not cause a delay in schedule;

does not cause costs to increase;

involves minimal effort to fix; and does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Inspection (by reviewing monthly report).

Is the contractor meeting established timeframes?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements require re-performance/rework. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Commitment to Customer Satisfaction and Business-like concern for its Customers' interest including responsiveness to internal and external clients.

Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

does not cause a delay in schedule;

does not cause costs to increase;

involves minimal effort to fix; and does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Sampling (by reviewing monthly report).

Is the contractor committed to high customer satisfaction?

How contractor proactive is to contractor? Is the contractor providing positive value to the government?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements required re-performance/rework. Substantial problems were encountered and were resolved in a less than satisfactory manner.

Overall Satisfaction Contract requirements met with few minor and no significant problems encountered.

Performance meets all technical and functional requirements in the PWS, and contains pertinent, useful, and informative data and information.

Contractor's technical performance meets all contract requirements.

Problems that are encountered are minor in nature, and are as follows:

does not cause a delay in schedule;

does not cause costs to increase;

involves minimal effort to fix; and does not affect overall contractor performance

All matters shall be resolved in a satisfactory and timely manner.

Random Sampling (by reviewing monthly report).

What is the governments overall satisfaction with the contractor?

Assignment of performance rating and criteria:

Excellent Performance meets all and exceeds contract requirements. Performance delivered with no required re-performance /rework; problems that are encountered are minor and resolved in a highly effective manner.

Acceptable Performance and deliverables meet all contract requirements. Performance delivered with no re-performance/rework; problems that are encountered are minor and resolved in a satisfactory manner.

Unacceptable Many contract requirements require re-performance/rework. Substantial problems were encountered and were resolved in a less than satisfactory manner.

INVOICING AND PAYMENT: All payments will be in US dollars, the United States currency. Invoices shall be submitted on a monthly basis.

ADDITIONAL INFORMATION

1. The PWS has been reviewed and has been determined to contain no services that are inherently Government functions.

2. Performance of this PWS may include access or exposure to private information subject to compliance to FAR Subparts 52.224-1 and 52.224-2.

3. Performance of this PWS may include dissemination of information / publishing subject to compliance with host Command requirements.

4. This PWS may include data that is subject to data right restrictions by the Command.

5. If applicable, all travel in support of Navy Medicine task orders must be deemed mission critical and written approval from the proper chain of command must be obtained before the travel takes place.

6. Notwithstanding any other provisions of this paragraph, the Government reserves the right to evaluate the quality of the professional, administrative, technical, and other services provided under this contract for purposes of contract inspection and acceptance. This includes reviewing all personnel files to ensure qualified personnel have been hired to support the required services on behalf of the government.