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Years of Experience
Date Last Verified
ProfileOutsourcing Senior Manager /Manager Duties: Responsible for leading all aspects of clinical contracting including managing study-level vendor selection, contracting and life-cycle management. End to end contracting process includes request for proposal and quotes, vendor assessment, decision summary and award notification, contracting and managing contract lifecycle. Provide overall management and oversight of study-level outsourcing and contracting activities within assigned therapeutic and/or functional areas. Lead project team activities related to contracting and outsourcing activities, including the preparation of Request for Proposals (RFPs), assessment and selection of appropriate vendors, and development of project scope, contracts and contract deliverables for outsourced work. Partner with clinical functions & procurement to influence new vendor selection based on historical vendor performance. Ensure that terms and conditions in vendor master service agreements do not conflict with study-level contractual obligations. Work closely with project teams and other internal functions to negotiate costs and contracts with vendors. Stay on top of industry best-practices by being experts in state-of-the art benchmarking tools and methodologies. Collaborate with the broader enterprise to recognize and implement business process, contractual, and/or financial synergies where appropriate. Work closely with Legal Affairs to develop and execute contracts in accordance with company standards. Ensure agreements are generated in a timely manner. Assist project teams in shaping scope and statement of work that enable effective downstream contract management. Draft, negotiate and execute project-specific agreements and amendments on time and with desired quality. Ensure that all decisions and documentation of the contracting process is compliant and audit-ready. Serve as a point person for CROs for supporting and answering all questions related to site contracting policies and guidelines. Maintain an ongoing level of intelligence about local and global vendors and translate that knowledge into effective contracting.
Qualification and Experience
For the Sr. Manager level, 8+ years of experience in pharma/biotech/CRO, including 7+ years in clinical contracting.
For the Manager level, 8+ years of experience in pharma/biotech/CRO, including 5+ years in clinical contracting.
Additionally, for both levels, we require the following education and experience: Bachelor degree is required. MBA or law degree is preferred. Experience in successfully executing clinical contracts from vendor selection through life-cycle management. Thorough understanding of the drug development process. People management experience preferred. Exceptional operational and negotiation skills. Ability to deliver with high quality at a fast pace. Excellent written and verbal communication skill. Good problem-solving and conflict resolution skills.
950 Wind River Ln
Gaithersburg, MD 20878