Site Contracts Specialist, Clinical Trials Experience

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

📋 Description

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

• May take the lead (with supervision) on multi-country projects, which includes negotiating and preparing contracts, budgets, and associated documents for participation in industry-sponsored clinical trials.

• Assists SSUL in finalizing country template contracts and budgets.

• Generates site-specific contracts derived from the country template.

• Provides support for submissions related to proposed contracts and budgets for sites.

• Aids in negotiating budgets and contracts with sites through the Site Contracts Service Centre and SSUL alongside the Sponsor until issues are resolved.

• Conducts quality control and facilitates the execution of CTAs, ensuring proper archival of documents into repositories and capturing metadata.

• Reviews contracts for thoroughness and precision, ensuring any necessary corrections are made and documented accordingly.

• 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 on the active management of ongoing contract issues, following up on all unresolved matters.

• Assists in creating amended contract and/or budget documents as required, prepares contract management documentation for projects, and enhances the contract/proposal or internal processes; introduces innovative ideas and solutions.

• Operates within the projected country/site contracting timelines, ensuring compliance and tracking milestone progress in the agreed SSU tracking system in real time.

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

• Facilitates contract execution by company signatories.

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

• Trains and mentors junior staff on departmental Standard Operating Procedures (SOPs) and ensures the quality of team deliverables.

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

• Acts as a communication bridge between site contracts staff and both internal and external clients.

• Provides functional direction and keeps internal and external teams informed about all contract statuses or outstanding issues.

• Prepares necessary correspondence.

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

• Reviews and adheres to Standard Operating Procedures (SOPs) and Work Instructions (WIs) promptly, keeps training records up to date, and ensures timesheet compliance.

⛳️ Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, a related field, or a comparable combination of education and experience.

• An advanced degree is preferred.

• Extensive experience in contracts management.

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

• Strong understanding of the clinical development process and the legal and contracting framework.

• Proficient in Microsoft Office Suite.

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

• Thorough understanding of the clinical trial process across Phases II-IV and ICH GCP.

• Good comprehension of clinical protocols and related study specifications.

• Excellent knowledge of clinical trial start-up processes.

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

• Strong vendor management skills.

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

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

• Quality-focused in all activities managed.

• Strong negotiation skills.

• Excellent problem-solving abilities.

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

• Ability to provide constructive feedback and guidance to peers.

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

🏝️ Benefits

• Comprehensive health benefits, including Medical, Dental, and Vision coverage.

• 401k with company matching.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO) and sick leave.