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.