Clinical Contracts Manager

Pleasanton, CA 94588

Posted: 08/19/2019 Employment Type: Contract Industry: Clinical Job Number: 6716

Essential 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.
  • Evaluates 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.

 

Knowledge, Skills, and Abilities:
  • 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).
  • Clinical Trial Services
  • Contracting: Master Services Agreement content and contract negotiations
  • Vendor Budgets

 

Formal Training/Education:

  • Bachelor’s in Business / Finance or industry related field required, Master’s degree preferred or equivalent combination of education and work experience.

 

Experience:

  • 6+ years of contract drafting, negotiation, and finalizing experience within Diagnostics and/or Pharmaceutical industry required
  • 6+ years of specific RFI, RFP, Contracting and/or Budget management experience required
  • 5+ years of clinical trial experience preferred
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