Dana-Farber Cancer Institute
Description
The Senior Research Program Manager, Pediatric Oncology works in partnership with the Principal Investigator (PI) to develop a long-term strategic plan to more efficiently manage tissue-based research projects, clinical research operations, collaborations, and regulatory approval. The position is also involved in the development of the first of its kind pediatric-specific liquid biopsy test for clinical return of results.
Responsibilities
- Responsible for submitting and maintaining regulatory approval for biology protocols and clinical trials originating from the Crompton Lab.
- Oversee management of tissue-based research drawing from multi-institutional and local trials.
- Coordinate work between collaborators involved in PI-initiated consortiums.
- Provide regulatory expertise to ongoing project to establish novel liquid biopsy CLIA test for return of results testing in collaboration with the Broad Institute and Boston Children’s Hospital.
- Work on “special projects” that may include support for the pediatric cancer genetics program and/or pediatric solid tumor program where PI has research leadership roles.
- Work strategically with PI to grow project management and regulatory infrastructure for the Crompton lab, cancer genetics program, and pediatric solid tumor program, including onboarding useful software tools to improve efficiency and create long-term stability for this aspect of the programs.
- Provide input on all lab recruits and partner strategically with the PI to right-size the project management/regulatory support for the lab as it continues to grow, including future hire(s) that would be expected to be direct reports to this position.
- Contribute creatively and scientifically to grant applications, project reports, manuscript preparation, and IRB applications.
- In collaboration with clinical research administration and grant managers, may maintain, monitor and reconcile all study and related grant finances. These may include budget development, expenditure tracking, procurement, salary offset worksheets and staffing.
Qualifications
- Master’s degree in cancer, genetics, genomics, or research required.
- Previous experience in the conduct of clinical trials and research operations required.
- 10 years of increasing expertise and responsibility in regulatory and specimen-based research required.
- Experience in project management from regulatory start up to close out.
- Extensive knowledge of specimen-based research and biobanking.
- Knowledge of genomics/genetics, scientific research, scientific writing.
- Experience in recruitment, hiring and management of research personnel.