Senior Site Contract Specialist – Contract Manager

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

📋 Description

• Oversee multi-country projects that entail negotiating and preparing contracts, budgets, and associated documents for industry-sponsored clinical trials.

• Create, review, negotiate, and finalize site-specific clinical trial agreements and investigator budgets.

• Conduct quality control checks and archive contract documents and metadata in designated repositories.

• Manage contract administration processes and coordinate related project agreements.

• Produce amended contract and budget documents while optimizing contract and proposal workflows.

• Align site contracts with sponsor master service agreement terms in partnership with the Site Contract Service Center and Legal.

• Collaborate with SSU leads, Clinical Operations, and Finance to verify departmental budget allocations and manage backlogs.

• Identify risks related to contracts and processes, offering proactive solutions.

• Cultivate working relationships with SSU leads, clients, and internal project teams.

• Report deviations and complex issues to leadership, the Site Contract Service Center, and Legal.

• Assist in business development and represent site contracts/Site Start-Up in internal or client meetings.

• Monitor country/site contracting timelines and milestone progress using SSU tracking systems.

• Partner with legal, finance, and clinical operations teams on legal and financial matters.

• Maintain contract templates, budget templates, site-specific documentation, and databases.

• Act as a communication liaison regarding contract statuses and unresolved issues.

• Train and mentor less experienced team members while keeping training materials up to date.

• Facilitate contract execution by authorized company signatories.

• Keep track of basic project financial components and contract hours/tasks.

• Adhere to SOPs, Work Instructions, training records, and timesheet requirements.

⛳️ Requirements

• A Bachelor's degree in a relevant field or equivalent professional experience.

• Moderate experience in contract management, preferably within a contract research organization or the pharmaceutical sector.

• Practical knowledge of a professional area acquired through education and work experience.

• Strong grasp of regulations, SOPs, and project requirements related to site identification.

• Exceptional negotiation and communication abilities.

• Capable of managing and analyzing site performance metrics.

• Experience in managing site confidentiality agreements (CDAs) and site information forms (SIFs).

• Preferred: Over 5 years of site contracts and study start-up (SSU) experience within a global CRO or pharmaceutical sponsor environment.

• Proven expertise in negotiating site clinical trial agreements (CTAs) and investigator budgets.

• Strong experience in drafting and managing site-specific CTAs based on country or global templates.

• Experience in handling contract amendments and protocol-driven modifications.

• Experience serving as an escalation point for complex contract, budget, or process challenges.

• Hands-on experience with SSU tracking systems and contract repositories.

• Demonstrated leadership in training and guiding junior staff members.

• Experience in supporting business development initiatives.

• Relevant certifications in clinical research or site management are preferred.

• Strong organizational and time management skills.

• Ability to work both independently and collaboratively within a team.

• Proficiency in relevant software and tools for site management.

• Detail-oriented with excellent analytical skills.

• Ability to manage multiple tasks and projects simultaneously.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical training and training in therapeutic areas.

• Peer recognition and a comprehensive rewards program.

• An inclusive workplace culture.

• Provision of a company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when necessary.