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Clinical Trial Contracts, Budgets and Study Documents Contractor

Brisbane, CA 94005

Posted: 04/10/2024 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 602103 Is job remote?: Yes Country: United States

Job Description

TITLE:  Clinical Trial Contracts, Budgets and Study Documents Contractor

POSITION SUMMARY: 

The Clinical Trial Contracts, Budgets and Study Documents Contractor plays a key role in the study start-up and clinical trial management processes. The consultant will play a key role in advancing the site activation and protocol amendment phases of our projects. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

This position is a remote position.


ESSENTIAL DUTIES AND RESPONSIBILITIES:
  • Responsible for preparing, negotiating, tracking, and executing a variety of agreements (e.g. Confidentiality Agreements (CDA), Clinical Trial Agreements (CTA), Budgets, and Letters of Indemnification (LOI), ICF’s etc.)
  • Involved in preparing, negotiating, and tracking amendments to the Clinical Trial Agreement (CTA) and Budget
  • Manages all required contractual agreements with investigator sites. This includes reviews of contract language, preparation of responses to negotiate contract and budget modifications, quality control, tracking and routing for execution.
  • Proactively identifies site contract related risks and potential roadblocks and escalates issues when appropriate.
  • Prepares contract approval timelines with investigators and leads efforts to obtain contract approval to meet study deliverables.
  • Maintains consistent communication with project team and sites regarding status of all contractual requirements. Liaise with legal when language with legal implications needs reviewed. Escalates to Development Operations Leadership when barriers cannot be resolved requiring legal and leadership intervention.
  • Supports the implementation and maintenance of contract-specific metrics and tracking to report and provide visibility to the project team into performance and deliverables to ensure timelines are maintained.
  • Effectively provides oversight over the CRO/third party vendor performance to address performance issues, ensure high quality and timely deliverables as per contracted scope of work.
  • Participates in corporate initiatives and actions that ensure the continued success of the company


QUALIFICATIONS:
  • Previous budgets and contracts site experience for global phase III trial required.
  • Ability to work in a regulated environment and collaborate with internal and external customers/vendors to meet project-specific goals.
  • Time-management-- Ability to manage high volume work and meet rigorous deadlines.
  • Flexibility to strategically manage negotiations with minimal oversight.
  • Exceptional communication skills-- Ability to interact with site, clients, and other functional areas as secondary project contact for contracting issues and questions; and
  • Organization-- Ability to manage time and project requirements based on study deliverables.
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