21 Jul
Senior Clinical Trial Manager
Vacancy expired!
- Coordinate site feasibility and selection activities, detailing the sites' capacity to successfully recruit and enroll subjects in the study as well as execute the study in accordance with the protocol and study timelines.
- Participate in and contribute to vendor selection process
- Oversee site performance, assist with subject eligibility and enrollment, identify and actively address subject recruitment challenges to keep subject enrollment on track, triage site questions, escalating to the CPM and management, as needed
- Manage site start up activities, including but not limited to regulatory document collection, site training, systems access, site activation
- Assist sites in central IRB on-boarding, ensure timely and accurate submission to IRBs, sponsors and master agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.
- Assure the provision of study supplies and materials to sites
- Contribute to process improvement for the Clinical Operations Department, including SOP development
- Assure the timeliness, quality and integrity of sampling handling procedures at sites through training and oversight
- Under the supervision of the CPM/CPL manage a portion of or all vendor activities
- Facilitate site monitoring activities, as needed, including follow through on action items
- Maintain study trackers with the support of the Clinical Trial Associate (CTA) to ensure real time and accurate reporting of study progress
- 5+ years clinical research experience, with at least 2 years in clinical operations, including Site Start up and management.
- Building and maintaining strong, trusting relationships.
- Able to recognize attention detail and demonstrate the ability to coordinate multiple sites independently and work constructively as part of a leadership team.
- Capability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.
- Very strong organizational skills, analytical and problem-solving abilities.
Vacancy expired!