The Clinical Program Manager has overall responsibility to support Clinical Operations. This will include leading and managing a clinical study team to ensure successful execution of a clinical trial, providing ongoing status updates to management on the progress of the clinical trial, proactively escalating risks and issues with mitigation plans in place, building strong internal and external relationships, and collaborating with cross functional teams. This position will require a candidate to lead clinical trials in a fast paced environment, drive continuous improvement efforts across Clinical Operations, represent Clinical Operations in key cross-functional activities, manage high performing teams, be flexible and navigate ambiguity, and effectively problem solve through innovative solutions while ensuring clinical trials are executed within compliance of regulations and of the highest quality.
- Accountable for all operational aspects of a clinical trial including quality, safety, and compliance.
- Develop and maintain enrollment and budget forecast.
- Proactively identifies potential issues/risks and implements appropriate mitigation plans to issue resolution.
- Contributes to the development, review, and implementation of departmental SOPs and processes including process improvement initiatives.
- Represents Clinical Operations at cross-functional meetings and accountable in making study level operational decisions. Reviews and approves all study related materials (i. e. protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans).
- Develops Clinical Operations study timelines. Provides regular study status update to management on study progress. Develops RFPs (Request for Proposals), leads vendor selection process, and manages external vendors (i. e. CROs).
- Responsible for overall management of vendors (i. e. CROs) and study monitoring.
- Responsible for the oversight of the Trial Master File (TMF). Ensures the conduct of the clinical trial is in compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulations.
- Leads department, development, or cross-functional initiatives. Provides guidance, mentorship, and career development to direct reports.
an operating company of Allegis Group® Inc., the largest staffing company in the U.S. At Aerotek, we work with many
industry leading organizations to perform their hiring, giving you access to positions you may not find on your own.
We concentrate on placing you in a position and with a company that fits your skills and career goals.