Clinical Contract & Pricing Specialist

Local candidates preferred in Warsaw, Indiana. This is a one-year contract position with a high chance of extension, full-time, and offering full benefit options.

About the role

As a Clinical Contract & Pricing Specialist, you will support the Business Strategy and Scientific Affairs Leaders by managing clinical trial and research-related contracts for multiple orthopedic programs. Collaborating closely with scientific/clinical affairs, project management, finance, compliance, procurement, and legal teams, this role oversees the development, negotiation, fair market value assessment, and execution of contracts (e.g., clinical trial agreements, confidentiality agreements, SOWs, amendments) with external partners, vendors, and investigative sites. You will ensure all contract activities align with company and departmental policies, timelines, and budgetary requirements, utilizing contract management systems such as Icertis, eMarketplace, Totality, Gensight PMT, and SharePoint.

This role is key to identifying and implementing process improvements and serving as a resource in resolving contractual, legal, and operational issues across partnering teams. You will prepare, negotiate, and finalize agreements and budgets related to clinical trials directly sponsored by the Company or through the Investigator Initiated/Collaborative Research Program. Additional responsibilities may include financial disclosures, sanction checks, conflict of interest activities, and Third-Party Intermediary due diligence.

Responsibilities

• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company-sponsored, investigator-initiated/collaborative studies, and real-world evidence studies.
• 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 Company 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.
• Track all aspects of legal documents and metrics.
• Determine potential needs for contract amendments and manage the amendment lifecycle.
• Work proactively to provide recommendations to improve processes and procedures to reduce cycle time, create savings, and improve efficiency in the initiation of clinical trial agreements.
• 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.
• Adhere to SOPs, ethics, and departmental compliance as determined by corporate, HCC, and QA guidelines.
• Ensure inspection readiness by maintaining complete, accurate, and timely data and essential documents in systems utilized for trial management according to expectations (metrics) and archiving retention requirements.
• Oversee the maintenance of an internal database for site-related costs and analyze changes.
• Ensure the maintenance of accurate, project-specific financial working files.
• Provide internal communication of important contract status, changes in contract requirements/regulations, and events.
• Maintain the highest levels of professionalism, ethics, and compliance at all times.
• Maintain electronic repository systems and ensure all files are uploaded and current.

Requirements

• Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, Biological Science, Finance, Business, and/or Law.
• A minimum of 3 years of relevant experience (or equivalent) required.
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) required.
• Experience in contracts management required; payment processing and HCC experience a plus.
• Previous clinical research or related technical experience and legal experience a plus.

Skills

• Understanding of Good Clinical Practices.
• Strong and proven negotiation and problem resolution skills.
• Understanding and application of regulations and standards applied in clinical areas/regions.
• Good presentation skills and effective influencing of others.
• Excellent written and oral communication skills.
• Demonstrated competencies in leadership in a professional and ethical manner.

Benefits

• Medical, Dental, and Vision coverage.
• 401K (no match).
• A variety of other benefits to choose from.
• Paid time off, including holiday, vacation, and sick/personal time.