Senior Clinical Trial Manager – Clinical Operations & CRO Oversight

Axiom Path, Inc.; Bridgewater (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Axiom Path, Inc. is seeking a Senior Clinical Trial Manager to lead and oversee global clinical studies, ensuring trial integrity and regulatory compliance.

You will coordinate regional activities, manage CROs and vendors, and partner with cross‑functional teams to drive study milestones and enrollment. Ideal candidates will have 5+ years in clinical trial operations, strong ICH‑GCP knowledge, and proven ability to navigate complex, matrixed environments while maintaining inspection readiness

Qualifications

• 5+ years of clinical trial management experience in pharma/biotech.
• Experience overseeing CROs, external vendors, and site activities.
• Strong understanding of ICH‑GCP and regulatory requirements.
• Ability to coordinate regional study activities and cross‑functional teams.
• Experience managing timelines, deliverables, risks, and data quality.

Responsibilities

• Support Clinical Operations leadership in planning, coordinating, and executing studies from initiation through closeout, ensuring ICH-GCP compliance.
• Oversee regional clinical trial activities, milestones, deliverables, and quality.
• Coordinate cross‑functional study teams, monitor progress, and address risks impacting timelines or execution.
• Manage CROs/vendors, evaluate performance against commitments and quality standards.
• Oversee regional site monitoring, resolve protocol deviations, patient safety concerns, and data quality issues.
• Participate in site feasibility and investigator selection based on qualifications and patient access.
• Contribute to study protocol and essential doc preparation and reviews.
• Partner with clinical/medical stakeholders for investigator engagement and enrollment activities.
• Participate in risk-based quality management and monitoring approaches.
• Develop clinical trial project plans, trackers, milestones, and risk mitigation strategies.
• Collaborate with Data Management to support data review and database lock readiness.
• Maintain inspection readiness and TMF quality throughout the study lifecycle.
• Identify changes in vendor scope or timelines and coordinate escalation.

Skills

Clinical trial management

CRO oversight

Investigator site operations

Regulatory compliance

ICH-GCP knowledge

Vendor management

Project planning

Data management workflows

Stakeholder management

Leadership

Education

Bachelor's degree in life sciences

Job description

Senior Clinical Trial Manager – Clinical Operations & CRO Oversight

Bridgewater, United States | Posted on 10/27/2026

• Industry Pharma/Biotech/Clinical Research
• State/Province New Jersey
• Country United States

Job Description

Be Part Of A High-Performing Team

Join a biotechnology organization dedicated to developing innovative therapies for patients with serious and rare diseases. The company operates in a highly collaborative, science-driven environment where accountability, integrity, respect, and patient-focused innovation guide clinical development activities.

This opportunity sits within an experienced Clinical Operations team responsible for advancing clinical research programs through disciplined trial execution, strategic partnerships, and cross-functional collaboration. Working alongside clinical development leaders, clinical scientists, and external research partners, this individual will help ensure clinical trials are conducted efficiently, ethically, and in accordance with regulatory requirements.

What's In Store For You

• Location: Bridgewater, NJ (work arrangement to be confirmed).
• Engagement: W2 only (no C2C/1099).
• Contract: Long‑term assignment, anticipated through October 2028.
• Support clinical development programs focused on addressing significant unmet medical needs.
• Collaborate with multidisciplinary teams across Clinical Operations, Clinical Development, Data Management, Medical Affairs, and external research organizations.
• Contribute to complex clinical studies involving global and regional stakeholders.
• Gain exposure to clinical trial oversight, risk‑based quality management, and strategic study execution.

How You Will Make An Impact

• Support Clinical Operations leadership in planning, coordinating, and executing clinical studies from initiation through closeout while maintaining compliance with ICH-GCP and applicable regulatory requirements.
• Oversee regional clinical trial activities, ensuring study milestones, operational deliverables, and quality expectations are achieved.
• Coordinate cross‑functional study teams, facilitate operational discussions, monitor progress, and proactively address risks that could affect timelines or trial execution.
• Manage oversight of CROs and specialized vendors, evaluating performance against contractual commitments, study metrics, timelines, and quality standards.
• Oversee regional site monitoring activities, working with CROs and investigative sites to resolve protocol deviations, patient safety concerns, data quality issues, and operational challenges.
• Participate in site feasibility and selection activities by assessing investigator qualifications, patient population availability, operational capabilities, and therapeutic area experience.
• Contribute to the preparation and review of 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 the implementation of 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 to support 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.

Do You Bring Proven Success in Clinical Trial Management and CRO Oversight?

• Minimum 5+ years of clinical trial management experience within the pharmaceutical or biotechnology industry, with demonstrated 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.
• Proven ability to work independently, exercise sound judgment, and proactively resolve operational challenges.
• Strong communication, stakeholder management, organization, 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.

Preferred Qualifications

• 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.