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Clinical Contracts Manager

Company:
SQA Solution
Location:
Pleasanton, California, United States
Posted:
November 05, 2019

Description:

Major Pharma company is looking for a Clinical Contracts Manager in South San Francisco. It is a 6 to 36 months contract on W2.

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.

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.

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

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