Senior Manager, JAX-GM Clinical Research Support
The Jackson Laboratory for Genomic Medicine (JAX-GM) in Farmington, CT is seeking a Senior Manager, Clinical Research Support. This role is responsible to the JAX-GM Site Director for serving in a key position in JAX-GM’s efforts to obtain and manage external grant, collaboration and contract funding that supports the clinical and translational research and service components of JAX-GM’s mission, goals, and objectives. Responsible for 1) all clinical research development and clinical affairs operations activities; 2) developing and implementing the clinical research strategies through functional interaction with the research team and other senior management; 3) coordinating with the Office of Sponsored Program (OSP) in all aspects of project administration of clinical research projects and clinical trials including the review of all proposals, budgets and contracts and tracking of all milestones and timelines; 4) the development of study related documents and overall direction of the clinical site(s) and 5) assuring compliance with the protocol and all regulatory guidelines.
- Provides support for faculty in preparing clinical research proposals for external and internal funding competition by designing, writing, implementing, and monitoring clinical research and IRB protocols.
- Management and oversight of all clinical research and study activities.
- Participates in regulatory strategy and matters especially as they pertain to clinical research and development activities, in close collaboration with OSP.
- Oversees clinical site management especially in regards to recruitment, monitoring, compliance and maintaining excellent partnerships with site PIs and staff to maximize subject enrollment.
- Establishes and approves (with outside vendor, Executive team, biostatistics group) scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
- Oversees data analysis, evaluation and reporting of clinical data including study reports, FDA and ethics committee progress/final reports, white papers and assist with manuscript preparation.
- Creates and directs clinical program/project-related advisory committees as needed, data and safety monitory board and/or expert consultants.
- Guides development of in-house clinical operations SOPs, guidelines and systems.
- Ensures that institutional policies, laws and regulations regarding sponsored research support are proactively addressed and adhered to.
- Travels to clinical sites when needed for site recruitment and review.