Site Contract Specialist – Contract Manager

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

📋 Description

• Lead projects across multiple countries that involve negotiation and preparation of contracts, budgets, and associated documentation for industry-sponsored clinical trials.

• Create and evaluate site-specific contracts using country clinical trial agreement templates.

• Submit proposed Clinical Trial Agreements (CTAs) and investigator budgets for review by sites.

• Negotiate budgets and contracts with sites, the Site Contracts Service Centre, SSU Lead, and sponsors.

• Conduct quality control, manage the execution of CTAs, archive documents, and record metadata.

• Oversee contract management processes that include agreements related to protocols, informed consent, institutions, investigators, vendors, consultants, and customers.

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

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

• Confirm departmental budget allocations and backlog with the SSU lead, Clinical Operations, and Finance.

• Identify operational risks and propose solutions; escalate deviations to leadership, the Site Contract Service Center, or Legal.

• Assist in business development and represent site contracts/SSU in internal or customer meetings.

• Monitor contracting milestones and adhere to projected country/site contracting timelines.

• Collaborate with legal, finance, and clinical operations departments on legal and budgetary matters.

• Maintain templates for contracts, budgets, site-specific files, and databases.

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

• Train and mentor junior staff members while maintaining training materials.

• Facilitate the execution of contracts by company signatories.

• Oversee financial aspects of projects and contract hours/tasks, escalating any discrepancies.

• Ensure compliance with SOPs and WIs, maintain training records, and guarantee timesheet compliance.

⛳️ Requirements

• Bachelor’s degree in a relevant field or equivalent experience.

• Moderate experience in contract management, particularly within a contract research organization or pharmaceutical industry.

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

• Strong comprehension of regulations, SOPs, and project requirements associated with site identification.

• Exceptional negotiation and communication skills.

• Capability to manage and evaluate site performance metrics.

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

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

• Experience managing multi-country studies is preferred.

• Expertise in negotiating site CTAs and investigator budgets is preferred.

• Experience in drafting and managing site-specific CTAs from country or global templates is preferred.

• Experience in managing contract amendments and protocol-driven changes is preferred.

• Familiarity with complex contract, budget, or process escalations is preferred.

• Experience with SSU tracking systems and contract repositories is preferred.

• Experience in training and mentoring junior staff is preferred.

• Experience in supporting business development activities is preferred.

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

• Strong organizational and time management skills.

• Ability to work independently as well as collaboratively within a team.

• Proficiency in relevant software and tools for site management.

• Detail-oriented with robust analytical skills.

• Ability to handle multiple tasks and projects simultaneously.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical training and therapeutic area education.

• Peer recognition and a total rewards program.

• Company car or car allowance may be available.

• Medical, dental, and vision health benefits.

• Company matching for 401k contributions.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

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