● 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 oversite of a Clinical Research Organization responsible for contract negotiations. Responsible for delivery on established targets/measurements.
● Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
● Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the pricing guidelines. Participate in and/or lead approval escalations as appropriate.
● 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.
● 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.
● 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.
● 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.
● CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC), Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
● Track all aspects of legal document and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.
● Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.