Clinical Contract Manager
4300 Hacienda Drive Pleasanton, CA 94588 US
Job Description
Job Description:
The Clinical Contracts Specialist Sr (position title may be Clinical Contracts Manager) works closely with project, people, and functional leaders across Clinical Operations & Biometrics, Procurement, Legal, Finance, and Suppliers to ensure appropriate contracts are in place for COBM projects and payments associated to contracts are issued to vendors.
This is a job requiring a combination of advanced skills and experience in drafting, negotiating, and finalizing contracts for COBM related services.
Responsibilities:
• Drafts, reviews and negotiates clinical trial agreements (Master Service Agreements, Work Orders, and Clinical Trial Agreements) and site budgets with US and ex-US institutions.
• Evaluate changes in study protocols to determine the impact on clinical trial site budgets; develop, negotiate and finalize budget amendments.
• Provide continuing support on executed agreements (e.g., drafting amendments, extensions and terminations, interpreting contractual language in response to issues or questions that arise).
• Work closely and communicate with members of the Lifecycle Finance teams and other internal stakeholders; provide timely updates on contract and site budget status’, identifying and escalating any potential critical path items as appropriate.
• Track, maintain and update assigned contract information within the COBM Clinical Trial Management System (CTMS) and other tracking tools, to ensure completeness and accuracy, as applicable.
• Works with Supplier Relationship Manager and Legal to establish Master Services Agreement (MSA) for as many suppliers as possible.
• Works with Supplier Relationship Manager to incorporate Key Performance Indicators into contracts for applicable suppliers.
• Establish Purchase Orders (PO), review related Invoices, track spend against contracts / PO’s, and report spend as necessary.
• Other tasks may be assigned from time to time to support overall COBM function.
• Other duties as assigned by management.
Qualifications:
(Required) Bachelor's Degree in Business / Finance or industry related field
(Required) 5 years of experience of contract drafting, negotiation, and finalizing experience within Diagnostics and/or Pharma industry
(Required) 5 years of experience of specific RFI, RFP, contracting and/or budget management experienceÂ
(Preferred) Master’s Degree in Business / Finance or industry related field
(Preferred) 4 years of clinical trial experienceÂ
?**CO/NY candidates may not be consideredÂ
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