Site Contracts Specialist I/II/Sr

This is a fully remote position, open to applicants in China.

📋 Description

• Oversee contract management processes, including the coordination of protocol, informed consent, institutional, investigator, vendor, consultant, and customer agreement documents at the project level.

• Lead multi-country projects involving negotiation and preparation of contracts, budgets, and related documents for industry-sponsored clinical trials, under supervision.

• Assist in the agreement of country template contracts and budgets, and create site-specific contracts.

• Aid in the negotiation of budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control, facilitate the execution of Clinical Trial Agreements (CTAs), archive documents, and capture metadata.

• Review contracts to ensure completeness and accuracy, and document necessary corrections.

• Support business development and represent site contracts/Site Start-Up at internal or customer meetings.

• Proactively manage ongoing contract issues, follow up on outstanding matters, and generate amended contract or budget documents as required.

• Monitor contracting milestones and adhere to forecasted country/site contracting timelines utilizing the SSU tracking system.

• Collaborate with legal, finance, and clinical operations teams on legal and budgetary matters.

• Facilitate the execution of contracts by company signatories.

• Maintain contract templates, site-specific files, and databases.

• Train and mentor less experienced staff and keep training materials updated.

• Act as a liaison between site contracts staff and both internal and external customers regarding contract statuses and pending issues.

• Monitor fundamental project financial aspects and contract hours/tasks, escalating discrepancies as necessary.

• Adhere to Standard Operating Procedures (SOPs) and Work Instructions (WIs), maintain training records, and ensure compliance with timesheets.

⛳️ Requirements

• Bachelor's degree in Business Administration, Public Administration, Public Health, or a related field, or an equivalent combination of education and experience.

• An advanced degree is preferred.

• Significant experience in contracts management is required.

• Experience in a contract research organization or the pharmaceutical industry is essential.

• Strong understanding of the clinical development process and the legal and contracting parameters involved.

• Proficient in Microsoft Office Suite.

• Comprehensive understanding of the clinical trial process across Phases II-IV and ICH GCP.

• Good grasp of clinical protocols and associated study specifications.

• Excellent knowledge of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Strong vendor management skills.

• Exceptional negotiating and problem-solving abilities.

• Excellent organizational skills with the capacity to manage multiple projects simultaneously.

• Ability to mentor, lead, and motivate junior staff members.

• Capability to provide constructive feedback and guidance to colleagues.

• Ability to contribute to a training and quality assurance plan within SSU and update SOPs/WIs as necessary.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive total rewards program.

• An inclusive company culture.

• Reasonable accommodations, when appropriate, to assist employees or applicants in performing essential job functions.