Site Contract Manager, Global Site Contracting
Found in: beBee jobs US - 7 days ago
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit for more information.
The Site Contract Manager will be responsible for the development and analysis of contractual relationships, including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization (CRO) responsible for contract negotiations. This individual will provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.
Principal 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 oversite 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.
- Exemplary customer focus with vision to drive solutions.
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