Scientific Program Manager

3 weeks ago

Bethesda, United States CAMRIS Full time

Overview:
CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today’s most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

**Responsibilities**:

- Provide accountability for the scientific deliverables and contributions of the Vaccine Research Center’s (VRC) Translational Science Team.
- Oversee essential team functions, ensuring that: All scientific objectives of VRC clinical trials are met; Clinical trial data is accurately analyzed and project timelines established by VRC leadership are met.
- VRC clinical trial data is managed according to best practices and securely archived in digital data management platforms.
- Clinical trial data is accurately communicated in a timely fashion to the public, VRC leadership and internal teams, and external stakeholders including academia, government and industry partners.
- Perform complex data analysis on first in-human clinical trial data, involving multiple procedures and a variety of technical approaches, including statistical and multivariant modeling.
- Process, analyze and interpret large, complex primary clinical trial datasets.
- Develop novel methodologies for analyzing immunological and pharmacokinetic data from both vaccine and monoclonal antibody clinical trials.
- Develop protocol scientific objectives and analytical laboratory testing plans for first-in-human clinical trials testing vaccines and therapeutics for infectious diseases.
- Prepare high level executive summaries of data for senior leadership to use in key decision making.
- Prepare complex scientific reports for publication in top-tier peer reviewed scientific journals.
- Provide expert advice and consultation related to clinical trials to laboratory and research staff.
- Provide insight to VRC Primary Investigators, scientists, and research staff on clinical and immune assessments assays.
- Author descriptions of complex immune response data and clinical trial results for regulatory reports, product licensees and internal and external stakeholders.
- Provide peer review as a scientific expert for original scientific manuscripts.
- Effectively collect, organize, store, protect, and process data; ensure useability of datasets.
- Lead and manage secure storage of clinical data on digital data management platforms according to industry standards and best practices.
- Provide raw data to collaborators and post to online repositories upon approved requests/as required by NIH data sharing standards.
- Assist FTL with integration of new team members by training junior team members to follow internal work instructions and standard operating procedures (SOPs) pertaining to data analysis and data management.
- Provide guidance related to clinical trials to laboratory staff.
- Participate in planning of new projects; provide expert advice and consultation on development of clinical trial protocols, analytical laboratory testing plans, and statistical analysis plans.
- Write and review technical protocols, work instructions, and reports documenting analytical development studies.

Qualifications:

- Ph.D. in Biomedical Science, Biology or a related discipline.
- Minimum of two (2) years of related experience; demonstrates knowledge of a broad range of scientific and technical areas.
- Experience in understanding and analyzing complex biomedical information and research findings.
- Ability to maintain and develop sources of information to gather data and transmit findings in areas of biomedical science.
- Skill in designing and creating documents, using desktop publishing software and office tools.
- Skill in using medical/scientific computer databases to search and collect information.
- Knowledge of graphing and reference and bibliographic software.
- Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required._

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