[Innovative Medicine] R&D, Senior Site Contract Manager, Site Engagement Group, Contract & Grants

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Position Summary:
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 responsible for contract negotiations.

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.
• Responsible for delivery on established targets/measurements.

Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects.

Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
• Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information.

Participate in and/or lead the approval escalation of grants as appropriate.
• Work with the global Contract and Centralized Services (CCS) team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language.

Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders.

Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
• Work proactively to improve processes and establish refinements that reduce cycle time, creat...