21 Jul
Senior Clinical Trial Manager
Massachusetts, Cambridge , 02138 Cambridge USA

Vacancy expired!

Position Title: Senior Clinical Trial Manager (Sr. CTM) A biopharmaceutical company located in the greater Boston area is looking for a Sr. CTM to join their team. The Clinical Trial Manager will be responsible for overseeing site management activities, delegated to a CRO and/or the direct management of assigned study sites from study start up through close out. The Sr. CTM will be responsible for one or more aspects of study management under the supervision of the Clinical Project Manager, including but not limited to, vendor management and oversight of monitoring.

Responsibilities:

The Sr. CTM will support the Clinical Project Manager (CPM) or Clinical Program Lead (CPL) in the execution of a clinical trial study as follows:
  • 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

Additional Qualifications:
  • 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.
If you or a Clinical Trial Manager you know think this could be an opportunity you would like to explore please send your most up to date resume to myself at c.shea(At sign) Realstaffing.com to discuss this role. All referrals welcome! Thank you!

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real please visit

Vacancy expired!


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