Clinical Study Manager
Accentuate Staffing is partnering with a biopharmaceutical company who is hiring for a Clinical Trial Associate to join their team. This is a direct hire opportunity, offering competitive pay and benefits while working a hybrid work schedule. The ideal candidate is a proven leader in clinical development with study management experience in the pharmaceutical or medical device industry.
Responsibilities:
- Collaborates with the project team and other CRO/vendor resources and timelines associated with study start-up activities.
- Initiates and trains sites to the study protocol, ensuring proper site adherence to clinical research regulations.
- Assists the project leader in maintaining operational plans, which are consistent with strategic corporate and R&D objectives.
- Plans and manages all materials to support the appropriate execution of clinical projects, including but not limited to distribution of documents, forms, supplies, equipment, and investigational product.
- Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections.
Requirements:
- Bachelor’s degree or higher in related field combined with three to four years as a CSM or CTM in a sponsor environment.
- Vendor and site management experience developing RFPs for vendors to support clinical studies.
- Ability to serve as lead for vetting vendors and sires for study participation as well as being Point of Contact both for CRO and vendor management.
- Experience leading the development of study specific protocols, consent forms, and other trial related materials.
- Skilled in ensuring the TMF is continuously updated and all documents are accounted for by the completion of the clinical study report.
