Senior Clinical Trial Manager (Remote)

Regulatory Jobs; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

BridgeBio is seeking a Sr. Clinical Research Associate/Clinical Trial Manager to support the Clinical Operations team in a US-based remote role with quarterly visits to San Francisco. You will oversee studies per protocols, ICH/GCP, SOPs, and regulatory requirements, providing quality oversight and study integrity.

You will lead site initiation, monitor performance, manage CROs and vendors, and contribute to study documents while ensuring TMF readiness. Travel up to 20% is required.

Qualifications

• Bachelor's degree in scientific/medical field or equivalent.
• 4–6 years of clinical study experience, preferably in biotech/pharma.
• Experience with CROs and vendor management in Clinical Operations.
• Experience supporting global studies in a fast-paced environment.

Responsibilities

• Oversee clinical studies from planning and start-up through execution, maintenance, and close-out in line with SOPs, ICH/GCP, and regulatory requirements.
• Lead site initiation activities, monitor performance metrics, identify risks, and coordinate actions.
• Manage CROs and other vendors (IRT, imaging, labs), ensuring deliverables and performance.
• Review monitoring documentation and oversee CRO monitors, identifying cross-site risks.
• Develop and maintain study documents (ICFs, CRFs, plans, TMF) under the study lead.
• Ensure the Trial Master File is complete and inspection-ready, driving resolution of gaps.
• Apply ICH E6(R3) GCP principles and drive quality in trial activities.
• Resolve protocol, safety, regulatory, and legal questions with sound judgment.
• Support budget negotiations and investigator meetings; travel up to 20%.

Skills

Vendor management

Monitoring

Regulatory knowledge

Communication skills

Remote collaboration

ICH E6(R3) knowledge

Education

Bachelor's degree or equivalent

Job description

BridgeBio is seeking a Sr. Clinical Research Associate/Clinical Trial Manager to support the Clinical Operations team in a US-based remote role with quarterly visits to San Francisco. You will oversee studies per protocols, ICH/GCP, SOPs, and regulatory requirements, providing quality oversight and study integrity.

You will lead site initiation, monitor performance, manage CROs and vendors, and contribute to study documents while ensuring TMF readiness. Travel up to 20% is required.