The Clinical Monitoring Research Program (CMRP) provides behavioral research and scientific support to the National Cancer Institute’s Division of Cancer Control and Population Sciences (DCCPS) for a wide variety of related program activities. In addition, the CMRP Regulatory Compliance and Human Subjects Protection Program provides management and coordination of assigned activities associated with the conduct of clinical research trials sponsored by the National Institute of Allergy and Infectious Diseases.
The Clinical Project Manager I (CPM I) provides essential program/project management expertise to support the comprehensive technical work for the DCCPS and RCHSPP and other initiatives and is responsible for performing comprehensive project and programmatic planning, research, subcontracting, analysis, communication and liaison activities. Work is performed independently with guidance and direction provided by the CPM II, as appropriate. The CPM I serves as one of the CMRP project leads and serves as a liaison between various Leidos Biomed, NCI and NIAID entities and collaborating offices, interacting with both scientific and administrative officials. Coordinates and communicates efforts within the assigned activities. These activities include organizing, planning, executing, reporting and evaluating the assigned program objectives. In addition, the CPM I is responsible for various subcontract planning, development and implementation activities including preparing statements of work (SOW), evaluating proposals, and serving as the technical representative for subcontract management oversight. Oversees and monitors the technical work of subcontractors and performs review and verification of subcontractor deliverables and invoices.
Qualifications: BASIC QUALIFICATIONS
- Possession of a Bachelor's degree from an accredited college/university in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree.
- Foreign degrees must be evaluated for U.S. equivalency.
- In addition to education requirements, a minimum of six (6) years related experience in a pharmaceutical, biotechnology and/or clinical environment.
- Effectively communicates, both verbally and in writing, with demonstrated expertise in grammar, syntax and format.
- Demonstrated strong skill set to problem-solve, plan, organize, collect data, and write/edit in order to function independently or collectively organize others to work within a team setting in the production of high quality deliverables complaint with established guidelines, practices, and procedures related to medical writing.
- Must be detailed-oriented; possess strong organizational skills and the ability to prioritize multiple tasks and projects.
- Ability to work in a clinical research setting both independently and within a team.
- Previous project management and/or study coordination experience including data management and subcontracting.
- Possess knowledge of FDA regulations and Good Clinical Practice (GCP).
- Knowledge of clinical trial fieldwork concepts and practices.
- This position is subject to obtaining a Public Trust Clearance.
- Project management, program management, grants and contracts, research subcontracts, cancer and infectious disease research
For more information about the Clinical Monitoring Research Program please visit http://cmrp.ncifcrf.gov/CMRP/Default.aspx
Leidos Biomedical Research, Inc., a wholly owned subsidiary of Leidos, operates the Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute. Our focus is on basic and applied science in cancer and AIDS. We maintain an integrated suite of advanced technologies backed by scientific expertise in areas such as genetics, genomics, protein science, proteomics, bioinformatics, high-performance biomedical computing, and nanotechnology. We develop new technologies to support cutting-edge science, and we develop and manufacture clinical-grade pharmaceuticals for first-in-human trials.
Leidos Overview:Leidos is an applied solutions company focused on markets that are seeing converging business and technological trends, and address basic, enduring human needs: defense and national security, health and life sciences, and energy, engineering and infrastructure. The Company's approximately 20,000 employees serve customers in the U.S. Department of Defense, the intelligence community, the U.S. Department of Homeland Security, other U.S. Government civil agencies and commercial health and engineering markets.
Leidos is an Equal Opportunity Employer M/F/D/V.
Job Posting: Jun 19, 2014, 10:30:13 AM
Primary Location: United States-MD-FREDERICK
Clearance Level Must Currently Possess: None
Clearance Level Must Be Able to Obtain: Public Trust
Potential for Teleworking: No
Shift: Day Job
Nearest Major Market: Washington DC
Job Segment: Biotech, Genetics, Materials Science, Nanotechnology, Manager, Science, Management