Clinical Outsourcing Manager
Edison-New Brunswick Metro Area, NJ
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
Competent knowledge of drug development processes, FDA, ICH, GCP regulations and guidelines
Competent with contract T&Cs, budgets, finance and financial negotiations.
Competent in computer skills, oral and written communication and multi- tasking
Competent with working in a team environment
Experienced in RFI/RFP development and proposal evaluation
- Responsible for the assessment, selection, negotiation, execution of contracts and relationship management of vendors providing externally contracted services managed by various 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. Shows confidence and competence at handling tenuous or challenging relations.
- Demonstrates knowledge of the industry, vendor base, and regulatory issues. Builds content of the contract; negotiates multi-layered terms. Focuses at the service, study, and program level. Works across all phases of clinical trials, across programs, and at the local and cross-regional level. Provides critical evaluations and implications of decisions. Understands vendor relationships and works closely with the Relationship Management Team.
- Acts as liaison within Finance, Legal and other internal functions and outside consultants to resolve issues and provide information, as required, facilitating contract negotiation and issue resolution ensuring that such contracts are consistent with quality, business, and corporate business objectives.
- Oversees the CRO outsourcing vendor selection process by managing the on-site operational assessment of vendors being considered.
- Prepare and maintain contract documentation files to ensure inspection readiness. Update database with all agreements/contracts/budget information.
- Identifies and recommends additional measurable cost-reduction programs for potential future development and implementation.
- Provides understanding of procurement principles, legal language and vendor selection criteria. Capitalizes on strengths of relationships/networks to effectively negotiate and influence