Senior Site Contracts Specialist

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

📋 Description

• Take the lead in negotiating, executing, and managing Clinical Trial Agreements along with related study budgets independently.

• Facilitate prompt startup and execution of studies.

• Act as a vital link among investigative sites, sponsors, and study teams.

• Engage in project teams to ensure that contract and budget services are delivered on schedule, within financial limits, and in compliance with relevant standards and regulations.

• Negotiate study-specific CDAs, CTAs, amendments, and other contractual documents.

• Assess site budget templates based on protocols and foresee potential negotiation challenges.

• Assist in the development of contract templates for new studies.

• Evaluate contracts for thoroughness and precision, ensuring professional formatting and compliance with guidelines.

• Monitor site interactions and provide comprehensive client status reports.

• Anticipate and track negotiation timelines, objectives, and milestones.

• Raise issues that could hinder execution timelines or scheduled Site Initiation Visits (SIVs).

• Work collaboratively across functions to ensure timely startup of clinical trial sites.

• Proactively identify and raise concerns before they escalate into critical risks.

• Provide mentorship and training to junior team members.

• Serve as a subject matter expert for contract training materials.

• Contribute to initiatives aimed at improving the site-contracts process.

• Recognize out-of-scope activities and prepare Change Orders alongside the study team.

• Perform additional duties as required.

⛳️ Requirements

• A bachelor's degree or international equivalent in a relevant field such as science/biology or English/communication.

• Over 3 years of experience in investigative site contracting, including familiarity with legal terminology and budget management.

• Proven experience in negotiating Clinical Trial Agreements, Confidential Disclosure Agreements, amendments, and related contractual documents.

• Proficient in managing site budgets and recognizing unnecessary or excessive Fair Market Value (FMV) requests.

• Capability to work with investigative sites in the US and Canada, and to oversee negotiations internationally as required.

• A master's degree or JD is preferred.

• Openness to work across various treatment areas.

• Ability to thrive in a fast-paced, dynamic setting and adjust priorities accordingly.

• Skill in identifying, escalating, and addressing contractual, budgetary, and site-related risks.

• Proficient in working cross-functionally with Clinical Operations, Project Management, sponsors, study teams, and investigative sites.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Life and Accidental Death & Dismemberment (AD&D) insurance.

• Short-term and long-term disability coverage.

• Tuition reimbursement opportunities.

• Fitness reimbursement program.

• Employee assistance program (EAP).

• 401(k) retirement plan.

• Generous paid time off and sick leave policy.

• Chance to earn performance-based bonuses.