Category: Scientific & Clinical
Job Title: Clinical Trial Manager
Location: Bethlehem, PA
Type: Full Time, Salaried with Benefits
Schedule: M-F Day Shift
- Report to Director, assisting with the management of vendors, sites, CRAs and contractors
- Responsible for the operations of clinical trials conducting supporting product registrations
- Perform daily clinical project management and study management functions; weekly project meetings, study performance metrics, maintain and manage TMF, create study protocols, write study reports
- Create and approve project-specific work practices and documents in conjunction with the CROs, in-house staff, or contractors
- Manage financial aspects of clinical projects including CRO, vendor and site payments, tracking and processing of payments.
- Provide monitoring oversight for the project through review of monitoring metrics, monitoring report review and approval, and co-monitoring.
- Assist with generation of clinical portions of regulatory submission documents
- Participates in preparation of regulatory submission responses to FDA inquiries
- Bachelors Degree required
- Study monitoring experience; previous experience as a field CRA
- 4+ years of experience working with a CRO or sponsor company in the Pharma/Biotech or Medical Device Industry
- Knowledge of Code of Federal Regulations, Good Clinical Practices, and FDA guidelines pertaining to medical devices and biologics.
- Knowledge of EU Medical Device and In Vitro Diagnostics Regulations preferred
- Ability to travel up to 30%
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.