CAMRIS is seeking a Clinical Development Project Manager to join the team for a Regulatory Affairs proposal at the The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) in Aberdeen, Maryland.
Reasonable Accommodation Statement:
To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
- Experience in development of clinical development plans and implementing protocols through oversight of Clinical Research Organizations or identifying, executing and managing a clinical research program from Phase 1 to Phase 3. Implementation and execution or oversight of Phase IV clinical studies desired.
- Experience with the development of multiple animal model plans to successfully guide development and approval of a drug or biologics with the FDA. Experience with developing and providing consultation in the execution of regulatory strategies for vaccines, orphan drugs, new mechanisms of action, rare diseases a plus.
- Demonstrated experience in leading, developing and managing cross-functional Translational Teams in the execution of a development plan.
- Demonstrated working knowledge of project management software (i.e. MS Project, Visio) to develop integrated development plans
- Experience in conducting decision analytics and conducting risk analyses and probabilities of technical and regulatory success
- Experience developing internal processes and procedures for the execution/oversight of sponsor responsibilities identified in 21 CFR, writing/reviewing/editing work objectives for clinical research organizations, developing/executing/overseeing clinical protocols
- Facilitate information flow between the COR, the contractor, and contract personnel.
- Oversee the hiring of new employees and serve as a key resource for all contract personnel. Work closely with the government on hiring to meet research project and mission goals.
- Provide on-site administrative oversight of contract personnel, to include pay, promotions, leave, work hours, conflict resolution, and disciplinary actions.
- Coordinate with the COR on research participant compensation and all travel for contract personnel.
- Identify and evaluate problems affecting research project and mission goals and provide solutions in a timely manner.
- Work closely with the COR to document the need for any changes to requirements.
- Ensure timely delivery of required reports.
Candidates for positions under contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.
- Minimum of a Master’s degree in Business Administration, Public Health, or other related business or health science field.
- Minimum of 5 years of experience as a Program Manager engaged in human subjects and/or animal research.
- Demonstrated experience in consultant and vendor sub-contracting establishment.
- Functional knowledge of Federal regulations on research with human subjects and/or animals.