Clinical Trial Site Manager

5 days ago

Mumbai, Maharashtra, India beBeeNegotiation Full time US$ 1,20,000 - US$ 1,70,000

Job Opportunity

We are seeking a highly skilled Site Contract Manager. This role will be responsible for managing contracts and agreements with clinical trial sites, ensuring compliance with regulatory requirements.

Key Responsibilities
  • Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company-sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversight of a Clinical Research Organization responsible for contract negotiations.
  • Provide support for negotiations in confidentiality agreements, informed consent forms, and other ancillary contract documents as required.
  • Participate in discussions related to the development of site investigator budgets aligned with fair market value.
  • Manage the contract amendment lifecycle.
  • Assume responsibility for all aspects of legal document and metrics tracking.
  • Provide support to review, authorize, and/or understand aspects of site payments.
  • Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
  • Comply with requests from QA and auditors.
  • Work proactively to provide recommendations to improve processes and establish refinements that reduce cycle time, create savings, and improve efficiency in the initiation of clinical trial sites.
  • Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution.
  • Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions.
  • Escalate issues as appropriate.
Requirements
  • Bachelor's degree in an appropriate scientific or business discipline.
  • 3 years of experience and/or equivalent competencies in pharmaceutical industry clinical research.
  • Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.).
  • A working knowledge of the clinical development process with 2 years of negotiation and contract experience.
  • Familiarity with clinical research processes.
  • Ability to work effectively in cross-function teams.
  • Strong and proven negotiation and problem-resolution skills.
  • Working knowledge of PCs, MS Office suite at a minimum, and database management.
  • Must demonstrate an innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work.
  • Previous experience working in virtual teams preferred.

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