Site Contract Specialist
SITE CONTRACT SPECIALIST
Prepare, negotiate and finalize agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations.
Provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.
Deliverables:
- 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 Sponsor 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.
Education and Experience Requirements:
- Bachelor's degree in appropriate scientific or business disciplines.
- 5 years' experience and/or equivalent competencies in legal/ pharmaceutical industry/clinical research.
- Working knowledge of the clinical development process with two (2) years of negotiation and contract experience.
- Accomplish substantial tasks with minimal supervision.
- Previous experience working in virtual teams.
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