Sr. Site Contract Specialist, FSP

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

📋 Description

• Oversee multi-country initiatives that involve negotiating and preparing contracts, budgets, and related documentation for industry-sponsored clinical trials.

• Generate, review, negotiate, and finalize site-specific clinical trial agreements and investigator budgets.

• Conduct quality control, facilitate contract execution, archive documents, and manage metadata.

• Manage contract management processes and coordinate associated agreement documents at the project level.

• Create amended contract and budget documents while optimizing contract and proposal workflows.

• Align site contracts with the terms of the sponsor's master service agreement in conjunction with the Site Contract Service Center and Legal.

• Verify departmental budget allocations and backlogs in collaboration with the SSU lead, Clinical Operations, and Finance.

• Identify risks related to contracts and processes, offering effective solutions.

• Build productive relationships with SSU leads, customers, and internal project teams.

• Report deviations to leadership, the Site Contract Service Center, and Legal.

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

• Monitor contracting timelines and milestone progression using the designated SSU tracking system.

• Collaborate with legal, finance, and clinical operations departments concerning legal and budgetary matters.

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

• Act as a communication liaison regarding contract statuses and outstanding issues.

• Train and mentor junior staff while keeping training materials up to date.

• Facilitate the execution of contracts by company signatories.

• Oversee basic project financial elements, available hours/tasks, timesheets, SOPs, and training records.

⛳️ Requirements

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

• Advanced degree is preferred.

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

• Management experience is preferred.

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

• Proficient computer skills in the Microsoft Office Suite.

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

• Excellent knowledge of clinical trial processes across Phases II–IV and ICH GCP.

• Solid understanding of clinical protocols and related study specifications.

• Comprehensive knowledge of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Competent vendor management skills.

• Strong organizational abilities with the capacity to manage multiple projects simultaneously.

• Exceptional communication, presentation, and interpersonal skills.

• Quality-focused approach.

• Strong negotiation and problem-solving capabilities.

• Ability to mentor and motivate junior team members.

• Capacity to provide constructive feedback and guidance to colleagues.

• Ability to contribute to an SSU training and Quality Assurance plan and update SOPs/WIs.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management.

• Technical training and therapeutic area education.

• Peer recognition and a comprehensive rewards program.

• An inclusive culture.

• Extensive resources including emerging technologies, data, science, and knowledge sharing.

• Collaboration with therapeutically or functionally aligned experts.

• Teamwork within a diverse group.

• Various career paths and employment opportunities.