Clinical Outsourcing Manager
Wayne Metro Area, New Jersey
- BA/BS degree in life sciences, business, Finance or equivalent with a minimum of 6 years work experience
4+ years in the pharmaceutical Industry; 3+ years in outsourcing and/or Finance supporting Phase I IV clinical trial services
Experience in oversight of CRO study execution required
- Responsible for the assessment, selection, negotiation, execution of contracts and relationship management of vendors providing externally contracted services managed by various clinical departments. Manage the entire Outsourcing process from Request for Proposal (RFP) to final contract. Is experienced and comfortable leading/overseeing complex initiatives of high dollar value from inception through to implementation. Demonstrates ability to handle global projects through established interactions with all regions as required. Oversees collaborations with all required departments to draft project and study-specific RFPs.
- Oversees the CRO outsourcing vendor selection process by managing the on-site operational assessment of vendors being considered.
- Competent knowledge of drug development processes, FDA, ICH, GCP regulations and guidelines
Competent with contract T&Cs, budgets, finance and financial negotiations.