Position Objective: Provide services as a Scientific Program Manager (Biospecimen Strategy) in support of the overall functions of the National Institute of Child Health and Human Development (NICHD) within the National Institutes of Health (NIH). Under this delivery order, the contractor will independently provide support services to satisfy the overall operational objectives of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The primary objective is to provide services and deliverables through performance of support services. Office of Data Science and Sharing (ODSS) seeks a Project Manager to provide project management and technical support in the development and implementation of an NICHD-wide biospecimen sharing strategy. https://www.nichd.nih.gov/about/org/strategicplan/scientificstewardship

Duties and Responsibilities:

• Design and support analysis of questionnaires, surveys, protocols, informed consent documents, training manuals, standard operating procedures (SOPs) and database management systems. 4
• Coordinate and document projects from beginning to completion; monitor and report the status of completion, funding and results attained; provide progress reports.
• Collaborate with staff on the planning, implementation, coordination and evaluation of programs and initiatives in the assigned specialty area of research. 3
• Spearhead compilation, analysis and organization of scientific, program and related information; and develop and/or lead data analysis/dyadic data analysis.
• Create both internal and external materials in the form of reports, summaries, emails, website content, video scripts, newsletters and social media. 5
• Develop periodic and special reports and procedures; search records and files, the internet, background materials and precedent references.
• Review and summarize materials and data; gather and coordinate information for review; conduct data entry and file maintenance; edit and/or prepare text, data and charts.
• Prepare briefing materials and summaries of meetings, workshops, and conferences.
• Use science writing skills to extract science themes and priorities during multidisciplinary science meetings. Attend committees and report relevant programmatic and scientific information to Institute leadership.
• Take and compile comprehensive notes and organize and edit content of meeting reports.
• Review short and long range planning proposals to ensure alignment with organizational objectives and mission.
• Assist in conducting literature searches and provide summaries of findings as part of preliminary planning for new research activities and directions.
• Work with staff on planning and implementing project-based activities; e.g., workshop planning, resource evaluation, communication strategy, assist with report writing/editing, etc.
• Contribute to the writing and development of executive summaries and reports to share with key partners.
• Provide a facilitative role among the team leaders aimed at coordinating strategies and goals into a focused Project Plan.
• Develop an overall operational plan for the proposed project after discussion with the Project Team: tasks to be completed, time scales and schedules, resources required, estimated cost of each task.
• Track implementation of the Project; review progress in relation to the plan; work with the Project Team to revise the plan as needed; develop and maintain a project-tracking document.
• Meet with upper level management on a regular basis to provide oral reports on the status of on-going projects and to receive new assignments.
• This is for Functional Responsibility for Technical Support - Perform and analyze literature and resource searches on biospecimen sharing best practices across the lifecycle (submission/acceptance, distribution, destruction), biorepository cost models, and relevant data standards, policies, regulations, and ethical frameworks. 1
• Technical Support - Develop process document templates for the Expert Determination Board and other working groups.
• Technical Support - Communicate results of literature and resources through documentation and presentations to staff and leadership audiences.
• Technical Support - Document use cases and develop requirements for technical development work, using human- centered design practices provided by ODSS team.
• Technical Support - Work with the NICHD Guide Liaison to support the development and release of Requests for Information.
• Technical Support - Analyze public comments in response to Requests for Information for communication to staff and leadership
• The functional responsibility is Project Management - Develop and track project plans and develop and update associated documentation for communication with NICHD staff and researchers. Support scheduling, develop agendas, meeting presentations, and meeting notes for all biospecimen strategy development and implementation related meetings and activities. 2
• Project Management - Configure and manage Teams/ SharePoint channels for all activities and working.
• Develop communications and outreach strategies for programs in relevant scientific areas; and draft strategic plans, standard operating procedures and guidelines for implementation of programmatic and administrative activities.
• Agendas, meetings notes, emails and related documentation for managing NICHD working groups: the NICHD Biospecimen and Data Expert Determination Board and an NICHD Biospecimen Sharing Committee. - Ad-Hoc
• Summaries of biospecimen sharing best practices across the lifecycle (submission/acceptance, distribution, destruction), biorepository cost models, and relevant data standards, policies, regulations, and ethical frameworks. - Ad-Hoc
• Requirements for biospecimen sharing workflows in the NICHD Data and Specimen Hub (DASH) and the new NICHD DASH BioBank. - Ad-Hoc
• Standard Operating Procedures for biospecimen sharing activities in NICHD DASH. - Ad-Hoc
• Well-organized and up-to-date Teams/SharePoint channels for all activities and working groups documentation and presentations to staff and leadership audiences on results of literature and resources search/analysis. - Ad-Hoc
• Project plans, status updates and progress reports to management - Ad-Hoc

Basic Qualifications:

• Master’s degree in miscellaneous biology.
• Collaborative Institutional Training Initiative (CITI).
• Demonstrates expertise with Microsoft Office Suite (Word, Excel, etc.)
• Knowledge of NIH grants and funding mechanisms, 45 Code of Federal Regulations (CFR) 46, Material Transfer Agents (MTAs), Human Subjects Research Protection, funding opportunity announcements, workshop and conference planning, research conduct and compliance, establishing collaborations, strategic planning, clinical research and trials, data collection, plain language, policy briefs, and biospecimens.

Minimum Qualifications:

• Certified in Healthcare Research Compliance preferred.
• PMP preferred.
• Ability to multi-task and pay close attention to detail.
• Excellent analytical, organizational and time management skills.
• Strong communication skills, both oral and written.

*This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job us at recruiting@gapsi.com. You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.

GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.

This position is contingent upon contract award.