Senior Site Contracts Specialist

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🔥 0 minutes ago

🏖️ New Jersey – Remote

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💵 $85k - $105k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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Logo of Everest Clinical Research

Everest Clinical Research

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Independently lead negotiation, execution, and management of Clinical Trial Agreements and associated study budgets • Support timely study startup and execution • Serve as a key liaison between investigative sites, sponsors, and study teams • Participate in project teams to deliver contract and budget services on time, within budget, and according to applicable standards and regulations • Negotiate study-specific CDAs, CTAs, amendments, and related contractual documents • Review site budget templates against protocols and anticipate negotiation issues • Support contract template development for new studies • Appraise contracts for completeness and accuracy and ensure professional formatting and adherence to guidelines • Track site interactions and provide descriptive client status updates • Forecast and track negotiation timelines, targets, and milestones • Escalate issues that may delay execution timelines or scheduled SIVs • Collaborate cross-functionally to support timely clinical-trial site startup • Identify and proactively raise issues before they become critical or create risk • Mentor and train junior staff • Act as a subject matter expert in contract training materials • Support site-contracts process improvement initiatives • Identify out-of-scope activities and prepare Change Orders with the study team • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree or international equivalent in a related field such as science/biology or English/communication • 3+ years of investigative site contracting experience with both the legal language and the budget • Experience negotiating Clinical Trial Agreements, Confidential Disclosure Agreements, Amendments, and related contractual documents • Ability to manage site budgets and identify unnecessary or higher-than-FMV requests • Ability to work with investigative sites in the US and Canada and oversee negotiations in other countries as needed • Master's or JD preferred • Willingness to work in many different treatment areas • Ability to work in a fast-paced, dynamic environment and adjust priorities • Ability to identify, escalate, and resolve contractual, budgetary, and site-related risks • Ability to work cross-functionally with Clinical Operations, Project Management, sponsors, study teams, and investigative sites

🏖️ Benefits

• Medical, dental, and vision coverage • Life & AD&D insurance • Short- and long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • 401(k) retirement • Generous paid time off and sick leave • Opportunity to earn a performance based bonus

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