Snr Clinical Contracts Manager
Edison-New Brunswick Metro Area, NJ
- BA//BS, JD or related advanced degree with 2+ years performing clinical contract negotiations and CRO oversight in the pharmaceutical industry
- .Knowledge of Good Clinical Practice (GCPs) as relates to clinical trial management required
Perform and manage all activities associated with the development of clinical site contracts from study concept through to final protocol.
Deliver clinical site agreements that protect business interests and compliance with regulations and laws concerning the same.
Develop Strategy and oversight for all activities for the development and execution of site contracts, for Sponsored study including contribution to Site selection process and site prioritization activities.
Prepare, distribute, negotiate, and drive to execution site contracts (MCSAs, CSAs, CRADAs, Appendices, etc.) with the appointed CRO or affiliate as appropriate.
Conduct project management for all site contract activities with CRO partners by tracking and measuring project and team timelines and progress through collection of cycle time metrics and other study specific quality; including but not limited to Key Performance Indicators (KPIs).
- Oversee an outsourced activity for clinical site contracts:
Ensure an Oversight Plan is in place for each sponsored protocol, including an escalation plan per study, propose where appropriate, solutions to issues that may arise during a project or contract life cycle.