Job Overview

Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements.

Essential Functions

• 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.
• 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 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.
• Track all aspects of legal document and metrics.  Determine potential needs for contract amendments and manage amendment lifecycle.

Qualifications

• Bachelor’s degree in related field
• 3 years’ experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
• Excellent communication skills (both oral and written).
• Familiarity with healthcare compliance and other relevant guidance
• Familiarity with clinical research processes.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com