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 J&J 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
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
CCS management and functional CCS support teams such as, legal, Healthcare Compliance (HCC), Risk Management, Privacy, and other stakeholders to obtain guidance and escalate issues as appropriate
Requirements
2 plus years Experience with contracts
Oncology clinical contracts experience required
Read write and speak fluent English
Experience in relevant areas involving contracts, negotiation, or sales
Bachelor’s Degree or international equivalent required
Prefer JD or advance degree but not required
Familiarity with working in service industry or project management environment