Site Contracts Specialist – Senior

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

📋 Description

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

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

• Assist in creating country template contracts and budget agreements, generate site-specific contracts, and submit the proposed contracts and budgets.

• Negotiate budgets and contracts with sites in collaboration with the Site Contracts Service Centre, SSUL, and Sponsor.

• Conduct quality control, facilitate the execution and archival of clinical trial agreements, and capture relevant metadata.

• Evaluate contracts for completeness and accuracy and document necessary corrections.

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

• Manage ongoing contract issues, follow up on unresolved matters, and generate amended documents as required.

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

• Collaborate with legal, finance, clinical operations, vendors, customers, and company signatories.

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

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

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

• Monitor basic project financial aspects, hours, and tasks, and escalate discrepancies as needed.

• Adhere to SOPs, WIs, training records, and timesheet requirements.

• Contribute to training and quality assurance plans and update SOPs/WIs.

⛳️ Requirements

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

• Advanced degree is preferred.

• Extensive experience in contracts management.

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

• Strong understanding of clinical development processes and legal and contracting parameters.

• Proficient in Microsoft Office Suite.

• Ability to manage competing priorities while remaining flexible and adaptable in high-pressure situations.

• Excellent knowledge of Phase II-IV clinical trial processes and ICH GCP standards.

• Good comprehension of clinical protocols and related study specifications.

• Strong grasp of clinical trial start-up processes.

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

• Competent vendor management skills.

• Exceptional written and verbal communication, presentation, documentation, and interpersonal abilities.

• Solid organizational skills with the capability to handle multiple projects simultaneously.

• Quality-driven mindset.

• Strong negotiation and problem-solving skills.

• Ability to mentor, lead, and inspire junior staff.

• Capability to provide constructive feedback and guidance to peers.

• Willingness to contribute to training and quality assurance initiatives and update SOPs/WIs.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive culture.

• Access to extensive resources, including emerging technologies, data, science, and knowledge sharing.

• Opportunities for diverse career paths and professional growth.