Scientific Project Manager

Additional Qualifications:

Certifications & Licenses

• Ph.D.

Field of Study

• Miscellaneous Biology

• Multi-Disciplinary or General Science

Software

• Graphing and reference and bibliographic software

• MS Office

• SharePoint

Skills

• Medical/scientific computer databases to search and collect information

• Designing and creating documents, using desktop publishing software and office tools

• Data analysis and graphing

• Scientific Writing and Communication

• Project management, website content management

Deliverables:

• Monthly status reports to include information on current and completed activities; problems encountered; corrective actions taken; and recommendations for the next reporting period - Monthly

• Status reports to assess progress, as requested by the Task Leader - Ad-Hoc

• Meet with lab members to present updates - Monthly

Statement of Work Details:

• Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing. - 1
• Monitor the work of the data analysis and scientific writing team members and provide senior scientific and technical leadership for team activities and deliverables. - 2
• Promote quality and consistency across data analysis and scientific writing team activities and deliverables through standardized approaches, collaborative review, application of best practices, and identification of opportunities for continuous process improvement. - 3
• Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints. - 4
• Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in clinical research. - 5

• Develops and assists staff implement policies and procedures related to the organization's scientific programs.

• Serve as Team Lead of the VRC CTP Data Analysis and Scientific Writing (DASW) team and provide senior scientific and technical leadership for team activities and deliverables.

• Coordinate and prioritize DASW activities and assignments in alignment with CTP clinical research priorities, study timelines, regulatory and public reporting requirements, and available resources.

• Maintain an integrated view of DASW projects and deliverables, including key milestones, dependencies, timelines, emerging issues, and resource or schedule constraints.

• Track team activities and deliverables; identify potential risks, delays, competing priorities, or other issues that may affect timely completion of work; and provide recommendations for resolution or escalation to CTP leadership, as appropriate.

• Serve as a primary DASW point of contact for CTP leadership and other CTP functional teams and participate in CTP Team Leads meetings.

• Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.

• Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in VRC clinical research.

• Provide technical guidance, mentorship, and training to DASW Scientific Advisors and other team members and support onboarding, knowledge transfer, and development of consistent scientific practices across the team.

• Promote quality and consistency across DASW activities and deliverables through standardized approaches, collaborative review, application of best practices, and identification of opportunities for continuous process improvement.

• Facilitate resolution of cross-functional scientific or operational issues affecting DASW activities and communicate unresolved or significant issues to appropriate CTP leadership.

• Collects, analyzes and creates scientific program information.

• Review scientific and analytical deliverables prepared by PhD-level DASW Scientific Advisors to promote scientific rigor, accuracy, completeness, consistency, and adherence to applicable requirements.

• Verify that clinical trial objectives and endpoints related to immunogenicity, pharmacokinetics (PK), and other assigned scientific analyses are appropriately addressed in study analyses and reporting.

• Review clinical trial analyses and results to assess whether conclusions are scientifically supported by the available data and are presented accurately and consistently across reports, publications, presentations, and other scientific communications.

• Verify that applicable clinical trial results are prepared and reported in accordance with relevant public reporting requirements and established CTP processes and timelines.

• Support appropriate management and documentation of clinical trial analytical data and verify that final data and analyses are maintained or archived in designated data management systems in accordance with applicable procedures.

• Review scientific content prepared for peer-reviewed publications, clinical trial result summaries, scientific presentations, posters, and other communications to promote clear, accurate, and appropriately contextualized reporting of VRC clinical trial findings.

• Apply current scientific and industry best practices in clinical trial data analysis, data management workflows, interpretation of clinical research findings, and scientific writing.

• Coordinates workshops and reports their outcomes.

• Serve as Chair of the VRC Scientific Review Committee and coordinate the scientific review of VRC clinical trial protocols in collaboration with committee members and other subject matter experts.

• Facilitate timely completion and documentation of scientific reviews and resolution of scientific comments to support protocol development and review.

• Provide subject-matter expertise in immunology, vaccinology, translational research, and the clinical evaluation of novel vaccines and monoclonal antibodies to CTP leadership, clinicians, scientists, and internal and external collaborators.

• Provide scientific and analytical consultation during clinical research planning and protocol development, including review of study objectives, endpoints, sampling strategies, and approaches for analysis and interpretation of clinical and immunologic data.

• Review and provide scientific input on Data Management and Sharing Plans, Analytical Plans, Statistical Analysis Plans, and other study-specific documents relevant to clinical trial data generation, analysis, and reporting.

• Collaborate with clinical investigators, statisticians, laboratory scientists, data managers, and other subject matter experts to promote alignment among protocol objectives, laboratory assessments, analytical methods, and planned statistical analyses.

• Evaluates current scientific programs and determines if changes need to be made.

• Coordinate with VRC laboratory and research scientists to monitor development, qualification, and readiness of assays required to support primary, secondary, and exploratory clinical trial objectives and endpoints.

• Track assay-development activities and timelines, identify dependencies or schedule variances that may affect clinical trial analyses or reporting, and communicate significant issues and recommendations to appropriate project teams and CTP leadership.

• Facilitate coordination among clinical, laboratory, statistical, and DASW personnel to support appropriate interpretation and integration of clinical and laboratory data.

• Participate as a member of the Sample Management team and coordinate clinical data and biological sample sharing with approved academic, government, and other research collaborators in accordance with applicable protocols, agreements, policies, and procedures.

• Provide scientific consultation regarding the selection and use of clinical samples and associated data to support collaborative translational research objectives.

• Assists with analyzing current scientific programs and developing and proposing new initiatives.

• Lead or contribute to the development and review of manuscripts, abstracts, scientific presentations, posters, clinical trial result summaries, and other scientific communications describing VRC clinical research.

• Present clinical trial findings and related scientific work through oral presentations and scientific posters at approved internal and external scientific meetings and conferences.

• Collaborate with investigators and multidisciplinary study teams to interpret clinical trial findings and communicate their scientific significance accurately and clearly to appropriate scientific and general audiences.

• Support publication planning and tracking of scientific deliverables to facilitate timely dissemination of VRC clinical research findings.

• Collaborates with management and prepares reports to keep them updated on new and ongoing programs and activities.

• Facilitate biannual reviews of DASW work instructions and related procedures and recommend revisions to improve scientific quality, consistency, efficiency, and cross-functional coordination.

• Coordinates staff responsible for developing, installing and maintaining scientific programs.

• Participate in biannual quality audits of the DASW and Sample Management teams and evaluate findings relevant to team processes and deliverables.

• Analyzes current policies and procedures and suggests and develops improvements.

• Draft or coordinate procedural revisions and other corrective or improvement measures in response to audit findings, recurring issues, changes in requirements, or identified opportunities for process improvement.

• Assists in preparing and developing future strategic plans.

• Monitor implementation of approved procedural changes and assess their effectiveness in improving DASW workflows and deliverable quality.

• Prepares and provides educational materials to staff.

• Identify trends, recurring challenges, and opportunities to standardize or improve clinical trial analysis, data management, scientific review, and scientific writing processes.

• Works closely with management to develop new initiatives that further scientific research.

• Facilitate sharing of best practices, lessons learned, and relevant scientific or procedural updates across the DASW team and collaborating CTP functional groups.

• Uses scientific expertise to review grant proposals and interacts with potential grantees to obtain additional information.

• Interact with scientists as needed to help overcome technical hurdles or provide additional insights or expertise regarding the preparation of scientific protocols.

• Develops project management documentation.

• Track team activities and deliverables; identify potential risks, delays, competing priorities, or other issues that may affect timely completion of work; and provide recommendations for resolution or escalation to CTP leadership, as appropriate.

• Review scientific and analytical deliverables prepared by PhD-level data analysis and scientific writing (DASW) team scientific advisors to promote scientific rigor, accuracy, completeness, consistency, and adherence to applicable requirements.

• Track assay-development activities and timelines, identify dependencies or schedule variances that may affect clinical trial analyses or reporting, and communicate significant issues and recommendations to appropriate project teams and CTP leadership.

• Draft or coordinate procedural revisions and other corrective or improvement measures in response to audit findings, recurring issues, changes in requirements, or identified opportunities for process improvement Monitors and reports progress to project owners.

• Serve as a primary DASW point of contact for clinical trial program leadership and other program functional teams and participate in Team Leads meetings.

• Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.

• Facilitate coordination and communication among DASW team members and clinical, laboratory, statistical, data management, regulatory, operational, and other personnel involved in clinical research.

• Conducts project analysis and reports to upper management.

• Review and provide scientific input on Data Management and Sharing Plans, Analytical Plans, Statistical Analysis Plans, and other study-specific documents relevant to clinical trial data generation, analysis, and reporting.

• Facilitate resolution of cross-functional scientific or operational issues affecting DASW activities and communicate unresolved or significant issues to appropriate program leadership Develops and tracks project budgets.

• Provide updates on DASW priorities, accomplishments, timelines, risks, resource needs, and other operational matters.

• Identify trends, recurring challenges, and opportunities to standardize or improve clinical trial analysis, data management, scientific review, and scientific writing processes.

• Researches project management best practices and new industry standards.

• Facilitate sharing of best practices, lessons learned, and relevant scientific or procedural updates across the DASW team and collaborating program functional groups.

• Support appropriate management and documentation of clinical trial analytical data and verify that final data and analyses are maintained or archived in designated data management systems in accordance with applicable procedures.

• Provides subject matter expertise and support to other project managers.

• Provide technical guidance, mentorship, and training to data analysis and scientific writing team members and other team members and support onboarding, knowledge transfer, and development of consistent scientific practices across the team.

• Provide scientific and analytical consultation during clinical research planning and protocol development, including review of study objectives, endpoints, sampling strategies, and approaches for analysis and interpretation of clinical and immunologic data.

• Collaborate with clinical investigators, statisticians, laboratory scientists, data managers, and other subject matter experts to promote alignment among protocol objectives, laboratory assessments, analytical methods, and planned statistical analyses.

• Develops overarching program and project management standards to ensure consistency and quality.

• Facilitate biannual reviews of data analysis and scientific writing teamwork instructions and related procedures and recommend revisions to improve scientific quality, consistency, efficiency, and cross-functional coordination.