Clinical Trial Manager

BioPhase Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

BioPhase Inc. is seeking an experienced Clinical Trial Manager to support global studies. You will oversee day-to-day trial activities, collaborate with internal teams and external partners, and ensure studies stay on track with timelines, budgets, and regulatory requirements.

The role requires strong CRO/vendor management, regulatory know-how, and the ability to travel internationally as needed. You will contribute to protocol development, TMF maintenance, and inspection readiness.

Qualifications

• 5+ years of clinical research experience, including global clinical trials.
• Endocrinology and/or rare disease trial experience preferred.
• Strong CRO/vendor management and monitoring oversight experience.
• Familiar with FDA regulations and ICH-GCP guidelines.
• Willing to travel internationally.

Responsibilities

• Manage clinical trial activities from start-up to closeout.
• Oversee CROs, vendors, sites, and monitoring.
• Track timelines, budgets, milestones, and deliverables.
• Support protocol development, study docs, and regulatory compliance.
• Maintain TMF and inspection readiness.
• Collaborate with cross-functional teams and study leadership.

Skills

Clinical trial management

Vendor management

Regulatory knowledge

Project coordination

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences/Healthcare

Tools

EDC platforms

TMF systems

Job description

We are seeking an experienced Clinical Trial Manager to support the execution of global clinical studies. This individual will oversee day-to-day trial activities, collaborate with internal teams and external partners, and ensure studies remain on track with timelines, budgets, and regulatory requirements.

Key Responsibilities:

• Manage clinical trial activities from study start-up through closeout.
• Oversee CROs, vendors, clinical sites, and monitoring activities.
• Track study timelines, budgets, milestones, and operational deliverables.
• Support protocol development, study documentation, and regulatory compliance.
• Identify study risks, troubleshoot operational challenges, and implement solutions.
• Review clinical data, monitoring reports, and protocol deviations.
• Maintain TMF documentation and support inspection readiness.
• Collaborate with cross-functional teams and study leadership.

Qualifications:

• Bachelor's degree in Life Sciences, Healthcare, or a related field.
• 5+ years of clinical research experience, including global clinical trials.
• Endocrinology and/or rare disease clinical trial experience preferred.
• Strong experience with CRO/vendor management and monitoring oversight.
• Knowledge of FDA regulations and ICH-GCP guidelines.
• Excellent organizational, communication, and project management skills.
• Comfortable collaborating across international time zones.
• Willingness to travel occasionally, including internationally.
• Experience with clinical trial management systems and EDC platforms preferred.