Site Contracts Specialist II/Sr

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

📋 Description

• Oversees all aspects of contract management processes, including coordination with relevant protocols, informed consent, institutional, investigator, vendor, consultant, and customer agreement documents at the project level.

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

• Assists SSUL in reaching agreement on country template contracts and budgets. Generates site-specific contracts from the country template and supports submissions for proposed contracts and budgets for sites.

• Aids in negotiating 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, facilitates the execution of CTAs, archives documents in repositories, and captures associated metadata.

• Reviews contracts for thoroughness and accuracy, ensuring that necessary corrections are made and documented appropriately.

• Supports business development efforts and represents site contracts/Site Start-Up (SSU) during internal or customer meetings.

• Collaborates with Contract Managers and team members on the active management of ongoing contract issues, following up on all outstanding matters.

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

• Operates within 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 signatories.

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

• Trains and mentors less experienced team members on departmental Standard Operating Procedures (SOPs), ensuring the quality of team outputs and keeping training materials up to date for the site contract team.

• Acts as a communication link between site contracts staff and both internal and external clients, providing functional guidance and keeping all teams informed about contract statuses or pending issues. Prepares correspondence as needed.

• Monitors basic financial aspects of projects and the availability of hours/tasks per contract, promptly escalating discrepancies.

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

⛳️ 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 contract management.

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

• Strong understanding of the clinical development process as well as legal and contracting parameters.

• Proficient in Microsoft Office Suite.

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

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

• Solid understanding of clinical protocols and associated study specifications.

• Strong comprehension of clinical trial start-up processes.

• Project management experience in a dynamic environment.

• Competent vendor management skills.

• Exceptional written and verbal communication, presentation, documentation, and interpersonal skills, along with a strong team orientation.

• Highly organized with a proven ability to manage multiple projects and communicate effectively.

• Committed to quality in all managed activities, with strong negotiation and problem-solving skills.

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

• Demonstrates the ability to provide constructive feedback and guidance to peers.

🏝️ Benefits

• We are dedicated to the growth of our people, offering opportunities for career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition, and a comprehensive total rewards program.

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