Repligen is evaluating the use of RG1068, synthetic human secretin, to improve visualization of the ducts of the pancreas when used in combination with magnetic resonance imaging (MRI).  Detailed assessment of the pancreatic ducts is important in the diagnosis and treatment of acute and chronic pancreatitis. 

RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion.  Secretin signals the release of fluids into the ducts of the pancreas which results in increased delineation of the pancreatic ducts and improved MRI imaging.

The Contract Clinical Project Manager is responsible for oversight of a prospective review of a clinical database of patients with pancreatitis and for managing three investigator-initiated INDs for new indications. Their primary deliverable is to ensure that protocols are executed in a timely fashion and that the output we are getting is appropriate. The Project Manager will coordinate the activities and deliverables of all study conduct partners by proactively identifying and managing issues; this will involve being active at the sites troubleshooting when problems arise and working with site investigators and study coordinators to make sure goals are realistic.

Requirements 

• Bachelor’s or equivalent degree, or higher.

• Clinical trial and data analysis experience required.

• Greater than 5 years of program/study management (or very closely related discipline) experience.

• Demonstrated effectiveness interacting with clinical investigators.

• Understanding of scientific/clinical principles and ability to work across different therapeutic areas.

• Knowledge of clinical development process including in depth knowledge and understanding of the principles of GCP.

• Working knowledge of data management processes and principles, including CRF design and query management.

• Ability to proactively communicate project issues and actions to mitigate risk and to ensure project members are aware of study status at all times.

• Position requires modest east coast travel (once/month on average) to investigator sites.

Interested candidates please email a cover letter and a resume in either a Word or PDF format to resumes@repligen.com