Senior Clinical Trial Manager – Clinical Operations & CRO Oversight

Axiom Path • Bridgewater Township, NJ

3d • Onsite

About The Position

The Senior Clinical Trial Manager supports clinical operations leadership in planning, coordinating, and executing clinical trials for serious and rare diseases. The role oversees regional trial activities, including site monitoring, operational performance, study milestones, and issue resolution, while ensuring compliance with ICH-GCP standards, applicable regulations, and study protocols.

The position coordinates cross-functional study teams and manages CROs and specialty vendors to maintain alignment on deliverables, timelines, quality expectations, and risks. It evaluates investigator sites, resolves site-level challenges, contributes to clinical and regulatory documents, supports risk-based quality and monitoring activities, and collaborates on data review and database lock milestones. The role also maintains inspection readiness through accurate and timely Trial Master File documentation and participates in investigator meetings, CRO governance, study initiation, and monitoring oversight activities as needed.

This is a long-term, approximately 24-month W2 assignment based in Bridgewater, New Jersey, scheduled for 40 hours per week, Monday through Friday.

Requirements

• Minimum 5 years of clinical trial management experience in the pharmaceutical or biotechnology industry, including direct responsibility for clinical study execution and operational coordination.
• Strong knowledge of clinical trial processes, drug development, ICH-GCP guidelines, and applicable local regulatory requirements.
• Demonstrated experience overseeing CROs, clinical research vendors, and external study partners.
• Hands-on experience managing regional clinical trial activities, site monitoring oversight, and study performance.
• Ability to coordinate complex clinical studies, manage competing priorities, and proactively resolve operational challenges.
• Experience supporting clinical trial documentation, study plans, protocols, informed consent forms, and regulatory or ethics committee submissions.
• Working knowledge of clinical risk management, study quality oversight, data integrity, and inspection readiness.
• Strong communication, stakeholder management, organizational, and problem-solving abilities.
• Ability to work independently while collaborating effectively across matrixed clinical development teams.
• Bachelor's degree in life sciences, healthcare, or a related discipline is preferred.

Nice To Haves

• Experience supporting large or complex clinical trials and multidisciplinary project teams.
• Exposure to rare diseases, orphan indications, or specialized patient populations.
• Familiarity with risk-based monitoring, centralized monitoring, and clinical data review processes.

Responsibilities

• Support clinical operations leadership in planning, coordinating, and executing clinical trials in compliance with ICH-GCP standards, applicable regulations, and study protocols.
• Oversee regional clinical trial activities, including site monitoring, operational performance, study milestones, and issue resolution.
• Coordinate cross-functional study teams to align clinical deliverables, operational timelines, quality expectations, and project risks.
• Manage CROs and specialty vendors, monitoring their performance against contractual commitments, milestones, quality indicators, and operational expectations.
• Evaluate investigator sites through feasibility assessments of site capabilities, patient access, investigator qualifications, and therapeutic expertise.
• Identify and resolve site-level challenges involving protocol adherence, patient safety, enrollment, data quality, and study administration.
• Contribute to the development and review of clinical protocols, amendments, case report forms, informed consent documents, study manuals, training materials, and regulatory submissions.
• Support Risk-Based Quality Management activities and, where applicable, implement risk-based and centralized monitoring strategies.
• Collaborate with clinical data management and scientific stakeholders on data review, issue resolution, and database lock milestones.
• Maintain clinical trial inspection readiness by ensuring accurate, complete, and timely Trial Master File documentation.
• Participate in investigator meetings, CRO governance discussions, study initiation activities, and monitoring oversight visits as needed.
• Track study progress, assess emerging risks, and develop corrective action plans to protect trial quality, timelines, and patient safety.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior