Sr. Site Contracts Specialist, FSP

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

📋 Description

• Oversee international projects, including the negotiation and preparation of contracts, budgets, and relevant documentation for industry-sponsored clinical trials.

• Create and review site-specific contracts derived from country clinical trial agreement templates.

• Submit proposed clinical trial agreements and investigator budgets for site evaluation.

• Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSUL, and sponsors.

• Conduct quality control and manage the execution and archiving of clinical trial agreements and associated metadata.

• Administer contract management procedures across protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents.

• Generate amended contract and budget documents while enhancing contract, proposal, and internal processes.

• Collaborate with the Site Contract Service Center and Legal to ensure site contracts align with sponsor master service agreement terms.

• Work alongside the SSU lead, Clinical Operations, and Finance to confirm departmental budget loads and backlog.

• Identify risks related to contracts and processes, propose solutions, and escalate deviations as necessary.

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

• Monitor contracting timelines and milestone progress within the SSU tracking system.

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

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

• Act as a communication liaison regarding contract statuses and pending issues; prepare necessary correspondence.

• Train and mentor less experienced staff while maintaining training materials.

• Engage in discussions on company goals, departmental objectives, and project aims.

• Facilitate contract execution by company signatories.

• Monitor the financial aspects and tasks of projects; escalate any discrepancies.

• Adhere to SOPs, Work Instructions, training-record, and timesheet requirements.

⛳️ Requirements

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

• Moderate experience in contract management, preferably within a contract research organization or the pharmaceutical industry.

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

• Proficient computer skills in Microsoft Office Suite.

• Customer-oriented with the ability to manage competing priorities and remain flexible and adaptable in high-pressure situations.

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

• Good familiarity with clinical protocols and related study specifications.

• Strong understanding of clinical trial start-up processes.

• Experience in project management within a fast-paced environment.

• Competent vendor management skills.

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

• Outstanding communication, presentation, and interpersonal skills.

• Quality-focused in all activities managed.

• Strong negotiation capabilities.

• Effective problem-solving skills.

• Ability to mentor and inspire junior staff.

• Capability to provide valuable feedback and guidance to colleagues.

• Ability to contribute to training and quality assurance plans within SSU and update SOPs/WI as needed.

• Advanced degree is preferred.

• Management experience is preferred.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Remote work arrangement (Remote (Pre-Approved)).