Senior Clinical Trial Manager – Global Clinical Operations & CRO Oversight

Axiom Path • Bridgewater Township, NJ

3d

About The Position

The Senior Clinical Trial Manager will lead operational planning, coordination, and execution of complex global clinical trials at an innovative, patient-focused biopharmaceutical organization. The role works across Clinical Development, Clinical Science, Medical Affairs, Data Management, CROs, investigators, research sites, and specialized vendors to deliver trials in alignment with study objectives, regulatory requirements, timelines, budgets, patient safety, data quality, and compliance standards.

The position may include accountability for overall study performance, regional execution, and key operational milestones. Responsibilities span site feasibility and activation, enrollment, CRO and vendor oversight, operational risk and quality management, clinical trial documentation, inspection readiness, data review, and stakeholder communication. The role also provides guidance and operational leadership to matrixed study team members.

The role is based in Bridgewater, New Jersey; the work arrangement is to be confirmed. It is a W2-only engagement, with a long-term assignment anticipated through October 2028, and a full-time schedule of 40 hours per week.

Requirements

• At least 7 years of clinical trial management experience in the pharmaceutical or biotechnology industry, with responsibility for trial execution and operational delivery.
• At least 2 years of indirect or matrixed team leadership experience, including coaching, mentoring, and influencing cross-functional contributors.
• Experience managing complex global clinical studies, including large-scale and/or early-phase development programs.
• Demonstrated expertise overseeing global CROs, specialty vendors, and outsourced clinical trial services.
• Strong understanding of the drug development lifecycle, clinical operations processes, ICH-GCP guidelines, and applicable regional regulatory requirements.
• Experience with site feasibility, study startup, site activation, enrollment performance, and investigator relationships.
• Working knowledge of clinical trial quality oversight, risk management, protocol compliance, inspection readiness, and Trial Master File requirements.
• Ability to interpret operational metrics, identify performance gaps, and develop practical solutions to clinical trial challenges.
• Strong project management capabilities, including timeline development, resource coordination, budget awareness, and milestone tracking.
• Experience collaborating with multidisciplinary clinical development teams in a global, matrixed organization.
• Excellent written and verbal communication skills, including the ability to influence stakeholders, manage conflict, and communicate with senior leadership.
• Demonstrated independence, sound judgment, proactive problem-solving, and ability to manage competing priorities.

Nice To Haves

• Experience supporting rare disease and/or orphan drug clinical programs is highly desirable.
• Bachelor's degree in life sciences, healthcare, or a related discipline is preferred.

Responsibilities

• Lead operational planning, coordination, and execution of complex global clinical trials in alignment with study objectives, regulatory requirements, timelines, and budgets.
• Provide clinical operations leadership and potentially oversee overall study performance, regional trial execution, and critical operational milestones.
• Drive site feasibility, investigator identification, site selection, site activation, and patient enrollment.
• Partner with cross-functional clinical teams to establish timelines, manage operational dependencies, identify risks, and implement corrective action plans.
• Oversee CROs and specialized service providers throughout the study lifecycle, including contractual commitments, performance, quality, and milestone achievement.
• Develop and maintain clinical trial management plans, operational documentation, study reports, and executive-level progress updates.
• Contribute to development and review of clinical protocols, amendments, informed consent forms, case report forms, regulatory submissions, and investigator-facing materials.
• Implement risk management and quality oversight practices, including risk-based quality management and applicable monitoring strategies.
• Collaborate with Clinical Development, Clinical Science, and Data Management on ongoing data review, issue resolution, and timely database lock.
• Maintain inspection readiness, clinical trial documentation, Trial Master File completeness, and compliance with applicable GCP and regulatory standards.
• Build productive relationships with investigators, research sites, CRO partners, and internal stakeholders to resolve challenges and maintain trial momentum.
• Guide, coach, and provide operational leadership to matrixed study team members, promoting accountability and effective communication.

Benefits

• Opportunity to lead complex global clinical studies in an innovative biopharmaceutical environment.
• Exposure to cross-functional clinical development teams, global CROs, and specialized research vendors.
• Opportunity to influence clinical trial delivery, operational quality, investigator engagement, and patient enrollment strategies.

What This Job Offers

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