Clinical Research Program Manager

Responsible for directing and managing a specified program within the clinical research operations unit, department, or division.

Provides leadership, guidance and direction for the day-to-day clinical research operations and activities, including authority to make independent decisions regarding program operations, administration, and governance.

Ensures compliant, efficient, and effective conduct of the clinical trials within the portfolio.

Establishes, implements, and evolves operational standards and monitors quality and progress of the program(s).

Note: A program is an ongoing organizational initiative with defined objectives and scope, but without a defined end or completion date.

• Oversees and/or manages the assigned recognized organizational clinical research program and has authority for day-to-day program operations and administration. May be responsible for program development or expansion. Plans and implements program operations, determines and develops governance, processes and/or guidelines, coordinates program activities and timelines, and determines and organizes resources to meet program objectives.
• May manage the research study intake process, including feasibility, review and endorsement and PRMC submission, as well as capturing all trials declined by program or department leadership.
• Identifies and defines any logistics, action items, changes, or information needed to effectively manage the program. Identifies barriers to timely study activation, efficient coordination, and participate to identify/implement potential solutions. May identify program participants and lead cross-functional teams in the administration, maintenance or expansion of the program.
• Interfaces with internal and external key stakeholders including other departments, leaders across the organization, representatives from external agencies/organizations in the management of the program to provide guidance, resolve issues, grow the program, and/or implement processes and/or solutions.
• Identifies growth opportunities and further efficiencies that impact the program and/or departments success and aids in development of strategic plans to achieve objectives. Manages study intake process, evaluates feasibility, and providing recommendations or making decisions to support the success of the clinical research program. Interfaces with internal/external stakeholders to maintain and further develop program growth, community outreach activities, as well as relationship building and maintenance.