Senior Clinical Trial Manager – Clinical Operations & CRO Oversight

Axiom Path•Bridgewater Township, NJ

About The Position

The Senior Clinical Trial Manager supports Clinical Operations leadership in planning, coordinating, and executing clinical studies from initiation through closeout. The role oversees regional trial activities, CROs and specialized vendors, clinical sites, study timelines, operational deliverables, quality expectations, and risk mitigation. It works closely with Clinical Development, Clinical Operations, Data Management, Medical Affairs, clinical and medical stakeholders, investigative sites, and external research organizations to support efficient, ethical, and compliant trial execution in accordance with ICH-GCP and applicable regulatory requirements. The position contributes to site feasibility and selection, investigator engagement, enrollment activities, clinical trial documentation, risk-based quality management, ongoing data review, database lock readiness, and inspection readiness. It maintains project plans, operational trackers, milestone reports, risk strategies, and Trial Master File completeness, and supports investigator meetings, study kickoffs, vendor governance discussions, and monitoring training. The role is based in Bridgewater, New Jersey, with the work arrangement to be confirmed. The engagement is W2 only and is a long-term contract assignment anticipated to continue through October 2028.

Requirements

At least 5 years of clinical trial management experience in the pharmaceutical or biotechnology industry, with responsibility for clinical trial operations and execution.
Strong understanding of clinical development processes, study lifecycle management, ICH-GCP guidelines, and applicable local regulatory requirements.
Demonstrated experience overseeing CROs, external service providers, and clinical trial vendors.
Hands-on experience coordinating regional clinical trial activities, monitoring oversight, and investigator site operations.
Experience managing clinical study timelines, deliverables, operational risks, and cross-functional activities.
Ability to evaluate site performance, address protocol compliance issues, and support clinical trial quality and patient safety.
Experience preparing, reviewing, or managing essential clinical trial documentation.
Strong understanding of clinical data management workflows, inspection readiness, and Trial Master File requirements.
Ability to work independently, exercise sound judgment, and proactively resolve operational challenges.
Strong communication, stakeholder management, organizational, and conflict resolution skills.
Ability to influence cross-functional teams and external partners in a matrixed environment.
Bachelor's degree in life sciences, healthcare, or a related discipline preferred.

Nice To Haves

Experience supporting clinical studies involving rare diseases or orphan drug indications.
Experience managing large-scale, multicenter, or operationally complex clinical studies.
Familiarity with risk-based quality management, risk-based monitoring, and centralized monitoring methodologies.
Experience supporting investigator engagement, site feasibility assessments, and study enrollment initiatives.
Exposure to clinical study data review, database lock preparation, and inspection readiness activities.

Responsibilities

Support Clinical Operations leadership in planning, coordinating, and executing clinical studies from initiation through closeout in compliance with ICH-GCP and applicable regulatory requirements.
Oversee regional clinical trial activities and ensure study milestones, operational deliverables, and quality expectations are achieved.
Coordinate cross-functional study teams, facilitate operational discussions, monitor progress, and proactively address risks to timelines or trial execution.
Oversee CROs and specialized vendors, evaluating performance against contractual commitments, study metrics, timelines, and quality standards.
Oversee regional site monitoring activities and work with CROs and investigative sites to resolve protocol deviations, patient safety concerns, data quality issues, and operational challenges.
Participate in site feasibility and selection by assessing investigator qualifications, patient population availability, operational capabilities, and therapeutic area experience.
Contribute to preparing and reviewing study protocols, amendments, informed consent forms, case report forms, investigator materials, operational manuals, and other clinical trial documentation.
Partner with clinical and medical stakeholders to support investigator engagement, site relationships, and enrollment-related activities.
Participate in risk-based quality management initiatives, including implementing risk-based and centralized monitoring approaches when applicable.
Develop and maintain clinical trial project plans, operational trackers, milestone reports, and risk mitigation strategies.
Collaborate with Data Management and Clinical Development stakeholders on ongoing data review, data quality activities, and database lock readiness.
Maintain inspection readiness throughout the study lifecycle by supporting Trial Master File completeness, documentation quality, and regulatory compliance.
Identify potential changes in vendor scope, project timelines, or operational requirements and coordinate appropriate escalation and documentation.
Support investigator meetings, study kickoffs, vendor governance discussions, and clinical monitoring training activities.