Site Contracts Specialist II/Sr – Sponsor Dedicated

This is a fully remote position, open to applicants in Serbia, +3 more countries.

📋 Description

• Oversee the management of contracts, coordinating documentation related to protocol, informed consent, institution, investigator, vendor, consultant, and customer agreements at the project level.

• Supervise multi-country projects, including the negotiation and preparation of contracts, budgets, and associated documents for industry-sponsored clinical trials.

• Assist in finalizing country template contracts and budgets, as well as creating 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 CTAs, archive documents, and gather metadata.

• Examine contracts for completeness and accuracy, ensuring necessary corrections are documented and made.

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

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

• Produce amended contract and budget documents while optimizing contract, proposal, and internal processes.

• Monitor country/site contracting timelines and track milestone progress using the designated SSU tracking system.

• Work in conjunction with legal, finance, and clinical operations departments on legal and budgetary matters.

• Facilitate the contract execution process by company signatories.

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

• Provide training and mentorship to less experienced staff on departmental SOPs and keep training materials updated.

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

• Oversee basic project financial aspects and contract hours/tasks, escalating any discrepancies as needed.

• Review and adhere to SOPs and WIs, update training records, and ensure compliance with timesheet protocols.

⛳️ Requirements

• BA/BS 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.

• Extensive experience in contracts management is required.

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

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

• Proficient computer skills in Microsoft Office Suite.

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

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

• Good grasp of clinical protocols and related study specifications.

• Excellent understanding of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Proficient vendor management skills.

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

• Exceptional organizational skills with a proven ability to manage multiple projects simultaneously.

• Strong negotiating and problem-solving abilities.

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

• Ability to provide constructive feedback and guidance to peers.

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

🏝️ Benefits

• Career development and advancement opportunities.

• Supportive and engaged management.

• Technical and therapeutic area training.

• Peer recognition programs.

• Total rewards program.

• Inclusive workplace culture.