[Job Description]

Position Summary:

Responsible for the development and analysis of site contracts 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.

The lead will assist with training of staff, facilitating clear and concise communications and assist Analysts with resolution of contracting and study related issues.

In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of 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 analyzing requirements and translating into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Responsible for reviewing all study specific tracking requirements for accuracy and completeness as well as delivering against contracting cycle time targets.

■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. Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the J&J pricing guidelines. Participate in and/or lead approval escalations as appropriate.

■Provide specialized support and guidance on negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.

■Provide project management oversight to CROs contracted to negotiate CTAs globally, inclusive of training and supervision to ensure adherence to timelines/targets.

■Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.

■May assist in review, authorization and/or management of payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.

■Exemplary customer focus with vision to drive solutions. This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.