Site Contracts Lead / Contracts Manager@Worldwide Clinical Trials
Verified
PROFESSIONAL EXPERIENCE
April 2023 to present Lead / Principal Specialist, Site Contracts (freelance, and after the contract ends, a permanent position)
Worldwide Clinical Trials
Responsibilities RESPONSIBILITIES:
• Serves as a Lead and subject matter expert on Clinical Trial Agreement processes at project level.
• Develops and provides expert and strategic pathways for the successful site contract execution within a project/program.
• Presents sites contract negotiation processes on kick-off / alignment meetings.
• Communicates and facilitates sites contracting strategies, contract turnaround/execution timelines, and sites contract tracking requirements.
• Agrees and negotiates Clinical Trial Agreements templates, fall back language and sites budget negotiation parameters with project lead and Sponsor.
• Supervises and mentors allocated Site Contracts Specialist, ensuring effective planning, effective communication, on time issues escalation, problem solving and execution.
• Recognizes potential problems/areas of concern and formulates contingency plans during the early stages of Clinical Trial Agreement development and escalates appropriately.
• Develops and implements mitigation plan to ensure the Clinical Trial Agreement deliverables are met.
• Resolves sites contracts negotiation issues.
• Prioritizes effectively and responds to urgent requests within internal team or Sponsor.
• Works closely with the Regulatory Affairs Lead, Site Activation Lead and/or other departments to ensure delivery of fully executed agreements in support of timely study site activation deliverables to meet departmental goals.
• Maintains a working knowledge of, and ensures compliance with applicable ICH-GCP Guidelines, local regulatory requirements, Worldwide SOPs and project specific procedures; maintains and assures quality of work generated.
• Negotiation and finalization or assistance in negotiation and finalization of Site Contracts with Worldwide Legal Department, project team, Sponsors, investigators and/or clinical sites,More...
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