ClinForce is currently seeking a
Senior Clinical Trial Manager for Durham, NC.
Successful candidate will be responsible for the following:
- Provide significant input into clinical and regulatory strategy sessions for assigned projects. Develop and implement clinical trial protocols and operational plans which are consistent with strategic corporate and departmental objectives and assumes primary accountability for the ongoing progress of those plans on assigned studies. Primary interface to clinical investigators and Key Opinion Leaders (KOLs), ensuring their input into protocols, reports and publications.
- Manage resources and timelines associated with all study start-up activities, including investigator agreements, central IRBs, regulatory documents, contractual agreements and device shipment authorizations. Manages the identification, recruitment and selection of investigators and testing laboratories for planned studies.
- Ensure the appropriate development of study documents, including informed consent forms, case report forms and instructions, site selection materials, procedural manuals, project newsletters and other project-specific documents required for the conduct of assigned studies with relatively little oversight.
Medical Device and In-Vitro Diagnostics experience, as well as 3 years personnel management experience.
BA/BS Degree