Site Contracts Specialist II/Sr – Sponsor Dedicated

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

📋 Description

• Oversee all processes related to contract management, which includes coordinating protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at the project level.

• Lead multi-country projects under supervision, which involves negotiating and preparing contracts, budgets, and related documents for industry-sponsored clinical trials.

• Assist in standardizing country template contracts and budgets while generating site-specific contracts.

• Aid in the submission of proposed contracts and budgets for various sites.

• Negotiate budgets and contracts with sites through the Site Contracts Service Centre and SSUL with sponsors until all issues are resolved.

• Conduct quality control and manage the execution and archival of CTAs, including capturing metadata.

• Review contracts for completeness and accuracy, ensuring all corrections are made and documented.

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

• Actively manage ongoing contract issues in collaboration with Contract Managers and team members, following up on unresolved matters.

• Create amended contract and/or budget documents, streamlining the contract, proposal, and internal processes.

• Monitor milestone progress in the agreed SSU tracking system in real time, adhering to country/site contracting timelines.

• Work alongside legal, finance, and clinical operations departments 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 while keeping departmental training materials updated.

• Serve as a communication liaison between site contracts staff and both internal and external customers.

• Provide updates on contract statuses and pending issues and prepare relevant correspondence.

• Monitor basic project financial aspects along with contract hours/tasks and escalate any discrepancies.

• Review and adhere to SOPs and WIs, updating training records and ensuring timesheet compliance.

⛳️ Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, a related field, or an equivalent combination of education and experience.

• An advanced degree is preferred.

• Extensive experience in contract management is essential.

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

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

• Proficient computer skills in Microsoft Office Suite.

• Ability to manage competing priorities while remaining flexible and adaptable in stressful circumstances.

• Excellent comprehension of the clinical trial process across Phases II-IV and ICH GCP.

• Good knowledge of clinical protocols and related study specifications.

• Strong understanding of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Effective vendor management skills.

• Outstanding written and oral communication, presentation, documentation, interpersonal, and teamwork skills.

• Strong organizational abilities with a proven track record of managing multiple projects.

• A quality-driven approach, along with strong negotiating and problem-solving skills.

• Capability to mentor, lead, and motivate junior staff.

• Ability to provide constructive feedback and guidance to peers.

• Capacity to contribute to a training and Quality assurance plan within SSU and update SOPs/WIs.

🏝️ 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 culture.

• Reasonable accommodations when appropriate, in compliance with the Americans with Disabilities Act.