Job Description

Responsibilities:

• Coordinate and develop contracts and change orders for newly awarded and on-going, single service, direct to contract and consulting projects and/or support the Contract Analyst team in the development of contracts and change orders.

• Work simultaneously on numerous contracts and/or change orders.

• Negotiation and Execution of Clinical Trial Agreements (CTA) and other related study documents:

  • Prepare, and review Study Site level budgets and contract templates and facilitate finalization and approval with the Sponsor, Legal, and any applicable internal personnel.

  • Proficiently negotiate CTAs, budgets and ancillary agreements.

  • Proficiently oversee all contractual documents and correspondence, including the facilitation of the indemnification process between Sponsor and Study Site.

  • Establish and maintain effective and proactive communication with Study Sites, Sponsors and internal personnel regarding the status of budgets, contracts and any other contract-related documents.

  • Ensure CTAs, budgets and ancillary agreements are negotiated within the Study specific agreed parameters and if not, appropriate approvals are obtained and documented.

  • As required, proficiently prepare, review and negotiate amendments to CTAs, budgets and ancillary agreements.

  • Conduct second level quality control review of completed CTAs, budgets and ancillary agreements prior to execution.

  • Serve as the internal liaison on study site budgets with respect to country needs and requirements.

  • Forecast Budget and Clinical Trial Agreements execution timelines and ensure they are achieved; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.

  • Prepare, review and negotiate Master Service Agreements with sites.

• Solicit input and review of contracts and change orders from the relevant operational departments.

• Ensure that payment terms follow recommended payment guidelines.

• Develop and maintain project files and tracking tools.

• Quality:

  • Review project documents and budgets prior to submission to their respective Contract Manager for final QC review.

• Communication:

  • Ensure clear and direct communication when corresponding (verbally or written) with the project team on the status of the contract and/or change order.

  • Lead and/or assist internal meetings required related to contracts and change orders.

Qualifications:

• Bachelor’s degree in law, Business Administration, or related field.

• 4+ years of experience in contract management or related field.

• Must be able to work hybrid, onsite in client San Diego office 2 days a week/3 days remote.

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