What You’ll Do:
• Draft, review, negotiate and finalize agreements with study sites in accordance with local/accepted process.
• Negotiate within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with
• Company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
• Ensure compliance to established negotiation parameters, authority approval, contractual process and client expectations.
• Ensure compliance of budgetary guidance, templates and process.
• Identify and assess legal, financial and operational risks in accordance with company and client contractual considerations, and escalate to appropriate level of the organization per established processes.
• Provide recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.
• Coordinate with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
• Achieve target cycle times for site activations.
• Ensure guidelines and process are followed for efficient escalation of out of parameter issues, as applicable.
• Complete tracking and reporting as required.
• May provide training and mentoring to junior staff.
• Participate in country process improvement initiatives, representing Global Site Contract activities within country team meetings.
• Act as country subject matter expert in review of Investigator Contracts training materials.
• Liaise with Global Site Contracts to ensure full compliance with established global processes and corporate directives.
• Complete periodic quality reviews and peer feedback reports.
• May act as lead with amendment/novation client projects and oversight of confidentiality agreement negotiations.