Location: Northern New Jersey/New York Metropolitan Area
Salary: $130,000 - $150,000
About the Opportunity
A growing global pharmaceutical company located in the northern NJ area currently is seeking an experienced Senior Manager of Clinical Research Operations. This is a great opportunity to work for a small, but growing company focused in Hematology, Orphan Diseases, Urology and Gynecology studies, and offering significant opportunities to contribute and advance throughout the organization.
- Manage selection process of CROs for regional or global clinical studies, performance of study vendors (e.g. CROs and central labs), activities for clinical site selection, investigator meetings and study initiation and data management vendors and statistical analysis vendors to ensure timely analysis output delivery in accordance with Statistical Analysis Plan.
- Support for the creation of study related documentation (protocol, ICF, CRF, operations manuals, etc.) and the coordination with clinical suppliers to ensure appropriate and timely delivery of clinical trial supplies to clinical sites
- Support creating and maintaining clinical SOPs and TMF as part of global QMS and TMF processes.
- Tracking of clinical data, regulatory documents, and patient enrollment information and data resolutions to assure the timely completion of clinical studies in line with approved clinical development plans.
- Assure compliance of investigational sites with SOPs, FDA regulations and ICH guidelines to assure that the studies are carried out fulfilling the requirements of the study protocols.
- Bachelor’s Degree in sciences or related field
- 5+ years of industry experience with 5+ years of drug development experience
- Phase II-IV clinical trials experience preferred.