Senior Clinical Trial Manager – Global Clinical Operations & CRO Oversight

Axiom Path, Inc.; Bridgewater (MA); Remote; USD 120,000 - 160,000; Full time

Job summary

Axiom Path is seeking a Senior Clinical Trial Manager to lead complex global trials in pulmonary indications. This role is remote within the United States and will coordinate cross-functional teams, sites, and CROs to ensure study success.

The candidate brings hands-on startup experience and deep knowledge of ICH-GCP, eTMF, and trial systems. The position is a long-term contract through October 2028, offering exposure to international teams and cutting-edge oncology and respiratory studies.

Qualifications

• Minimum 7+ years of clinical trial management experience in pharma, biotech, or CROs.
• Experience with large, international Phase III trials and pulmonary/respiratory indications is preferred.
• Hands-on startup, ICF review, IRB/EC feedback resolution, and site budget negotiations.
• Proven oversight of CROs, vendors, and outsourced activities.
• Strong Excel skills for detailed trackers and timelines.
• Familiarity with Veeva Vault eTMF and Medidata Rave systems.

Responsibilities

• Coordinate multinational trials with emphasis on Phase III pulmonary studies.
• Lead startup activities: ICF reviews, IRB/EC feedback, site budgets.
• Oversee CROs and vendors to ensure timelines and quality.
• Maintain Excel-based trackers for startup progress and milestones.
• Support enrollment and ongoing study management; ensure regulatory compliance.
• Provide operational updates to study leadership and manage deliverables.

Skills

Clinical trial management

Phase III trials

IRB/EC coordination

CRO oversight

Stakeholder management

Excel proficiency

eTMF systems

Education

Bachelor's degree in life sciences

Tools

Veeva Vault eTMF

Medidata Rave

Job description

Senior Clinical Trial Manager – Global Clinical Operations & CRO Oversight

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

• Industry Pharma/Biotech/Clinical Research
• Date Opened 10/27/2026
• Job Type Contract
• State/Province New Jersey
• Country United States

About Us

Axiom Path is an AI-first recruiting and staffing firm delivering RPO, MSP, and direct-hire solutions to enterprise clients across the U.S. Our team of experienced recruiters, supported by purpose-built automation, moves faster and communicates better so clients get qualified talent sooner and candidates get a clear, responsive process from first contact to start date.

Job Description

Be Part Of A High-Performing Team

Join an innovative biopharmaceutical organization advancing clinical research for patients affected by serious and rare diseases. The organization brings together clinical development, scientific, and operational professionals to deliver complex global studies through collaboration, accountability, and a strong commitment to patient safety.

The Clinical Operations team is supporting multiple international studies within a pulmonary development program. With several studies actively progressing through startup, the team needs an experienced Clinical Trial Manager who can contribute immediately to study execution, coordinate global research partners, and ensure sites and vendors are positioned for success.

This opportunity is particularly suited to a hands-on clinical operations professional with experience in pulmonary or respiratory indications, global Phase III trials, and the operational details necessary to keep complex research programs moving forward.

What's In Store For You

100% remote position within the United States.

East Coast or Midwest location preferred; other US locations considered with schedule flexibility.

Full-time, 40 hours per week.

Long-term contract opportunity through October 2028.

Engagement: W2 only (no C2C/1099).

Opportunity to support large, international Phase III clinical trials in pulmonary and rare disease indications.

Direct collaboration with global study teams, international CROs, clinical research sites, and specialized vendors.

Significant ownership of clinical trial startup activities, operational execution, and vendor coordination.

• Scheduling consideration: Candidates must be comfortable supporting early morning meetings and collaborating with European clinical research teams.
  

How You Will Make An Impact

Coordinate and execute operational activities for complex, multinational clinical trials, with particular emphasis on Phase III pulmonary studies.

Drive clinical trial startup activities, including informed consent form reviews, site budget evaluation, and coordination of site budget negotiations.

Review ICF revisions and feedback from Institutional Review Boards and Ethics Committees, working with appropriate stakeholders to resolve outstanding requirements.

Evaluate clinical research site budgets, identify discrepancies, and support negotiations to facilitate study activation.

Oversee clinical research vendors and coordinate closely with CRO partners to ensure operational deliverables, timelines, and quality expectations are met.

Maintain sophisticated Excel-based operational trackers to monitor startup progress, site-level activities, milestones, and outstanding issues.

Monitor clinical trial performance, proactively identify risks, and coordinate corrective actions to prevent operational delays.

Collaborate with international stakeholders and study teams, including European partners, to maintain execution timelines.

Support enrollment and ongoing study management activities, including monitoring trip report review and issue escalation as trials progress.

Work with clinical trial systems, including electronic Trial Master File platforms, interactive response technology, and electronic data capture systems.

Contribute to inspection readiness, documentation accuracy, and compliance with ICH-GCP and applicable regulatory standards.

Provide clear operational updates to clinical study leadership while independently managing assigned deliverables.

Requirements

Are You An Experienced Global Clinical Trial Manager Ready To Make An Impact?

Minimum 7+ years of clinical trial management experience within pharmaceutical, biotechnology, or CRO environments.

Recent experience supporting or managing large, international Phase III clinical trials.

Strong preference for pulmonary or respiratory clinical trial experience, particularly involving IPF, PPF, ILD, PAH, or related indications.

Proven hands-on experience with clinical trial startup activities, including ICF review, IRB/EC feedback resolution, and clinical site budget evaluation or negotiation.

Demonstrated experience overseeing CROs, clinical trial vendors, and outsourced study activities.

Strong Microsoft Excel proficiency, including managing detailed and complex clinical trial operational spreadsheets.

Familiarity with electronic Trial Master File systems such as Veeva Vault eTMF.

Working knowledge of clinical trial platforms such as IRT systems and electronic data capture tools, including Medidata Rave.

Thorough understanding of clinical trial execution, ICH-GCP regulations, clinical documentation, and operational quality requirements.

Ability to work independently, coordinate competing priorities, and resolve issues proactively in a global, matrixed environment.

Strong written communication, organization, stakeholder management, and analytical problem-solving skills.

Flexibility to participate in early morning meetings supporting European stakeholders and global trial timelines.

Bachelor's degree in life sciences, healthcare, or a related field strongly preferred.

Experience mentoring or influencing cross-functional contributors is valuable.