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. Escalate as appropriate.
Provide specialized support and guidance on negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents, as required.
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.
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.
Adhere to SOPs, ethics and departmental compliance as determined by departmental management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and applicable corporate processes.
Comply with requests from QA and auditors.
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
• Bachelor’s degree in appropriate scientific or business disciplines
• 5 years experience and/or equivalent competencies in the field of Site Contract Negotiation
• Excellent communication skills (both oral and written)
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
• Comprehensive knowledge of clinical research processes
• Ability to work effectively in cross functional teams
• Strong initiative and proven self-starter
• Strong and proven negotiation and problem resolution skills
• Working knowledge of PCs (MS Office suite at a minimum) and database management
• Advanced fluency in English is required
• Must demonstrate innovative spirit, have strong interpersonal skills, and ability to accomplish substantial tasks with minimal supervision
• Previous experience working in virtual teams preferred