Site Contracts Specialist – Sponsor Dedicated

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

📋 Description

• Manages all processes related to contract management, ensuring coordination with applicable protocols, informed consent, institutional, investigator, vendor, consultant, and customer agreement documents at the project level.

• May oversee multi-country projects (with supervision) including the negotiation and preparation of contracts, budgets, and related documents for participation in industry-sponsored clinical trials.

• Assists the Site Start-Up Lead (SSUL) in agreeing on country template contracts and budgets.

• Creates site-specific contracts based on country templates.

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

• Supports the negotiation of budgets and contracts with sites through the Site Contracts Service Centre and SSUL in collaboration with the Sponsor until all issues are resolved.

• Conducts quality control and coordinates the execution of Clinical Trial Agreements (CTAs), along with the archival of documents into repositories and metadata capture.

• Reviews contracts to ensure completeness and accuracy, making necessary corrections and documenting them appropriately.

• Supports business development efforts and represents site contracts/Site Start-Up (SSU) in both internal and external meetings.

• Collaborates with Contract Managers and team members for the active management of ongoing contract issues; follows up on all pending contract matters.

• Assists in generating amended contract and/or budget documents as needed, preparing contract management documentation for projects, and streamlining internal processes; introduces innovative ideas and solutions.

• Adheres to forecasted country/site contracting timelines, ensuring compliance and tracking milestone progress in the agreed SSU tracking system in real-time.

• Works with internal and external legal, finance, and clinical operations departments, effectively communicating and clarifying legal and budgetary issues.

• Facilitates the signing of contracts by company representatives.

• Maintains contract templates and site-specific files and databases.

• Trains and mentors less experienced staff on departmental Standard Operating Procedures (SOPs) and ensures quality in team deliverables.

• Updates and maintains training materials for the site contract team.

• Serves as a communication liaison between site contracts personnel and internal/external clients.

• Provides functional guidance and keeps teams informed of all contract statuses and pending issues.

• Prepares necessary correspondence.

• Monitors basic financial aspects of projects and the allocation of hours/tasks per contract; escalates discrepancies promptly.

• Reviews and adheres to Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeping training records current and ensuring timesheet compliance.

⛳️ 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.

• Essential experience in a contract research organization or the pharmaceutical industry.

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

• Proficient in Microsoft Office Suite.

• Customer-focused with the ability to manage challenging priorities while remaining flexible and adaptable under pressure.

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

• Good understanding of clinical protocols and associated study specifications.

• Strong grasp of clinical trial start-up processes.

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

• Competent vendor management skills.

• Outstanding written and oral communication, documentation, and interpersonal skills, with a strong team-oriented approach.

• Highly organized with a proven ability to manage multiple projects and excellent communication.

• Quality-driven in all activities undertaken.

• Strong negotiation skills.

• Excellent problem-solving abilities.

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

• Ability to provide constructive feedback and guidance to colleagues.

• Contributes to a training and quality assurance plan within SSU and updates SOPs/WIs accordingly.

🏝️ Benefits

• We are dedicated to developing our employees through career progression opportunities; supportive and engaged management; technical and therapeutic training; peer recognition; and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.

• Driven to Deliver – embodies the passion of our team members who strive daily to create solutions that can significantly impact lives.

• Continuous development and various potential career paths are available.