Senior Clinical Trial Manager- Imaging Study
BridgeBio
5 hours ago
Remote friendly (United States)
United States
$162,700 - $191,000 USD yearly
Clinical Research and Development
Responsibilities:
- Execute and manage assigned clinical studies while ensuring Good Clinical Practices (GCP) compliance, high study quality, and timely completion.
- Lead the Clinical Study Team for assigned projects; may lead one or more clinical studies from concept to protocol and achieve milestones (e.g., First Patient In, Interim Analysis, Database lock).
- Manage external vendors and contract research organizations; may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs).
- Prepare/review/approve study documents (e.g., Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, Laboratory Manual).
- Coordinate and design study materials (e.g., CRFs, patient diaries, study participation cards, and source documents).
- Manage operational and monitoring activities at the study level/site level to assure adherence to GCP, SOPs, and study protocols.
- Negotiate and manage vendor work agreements and site contracts.
Qualifications:
- Bachelor’s degree in a scientific discipline or equivalent (advanced degree preferred).
- At least 8 years of biopharma industry experience with relevant clinical trials (biotechnology, pharmaceutical, CRO, or medical device industry), including at least 2 years managing clinical trials.
- Vendor management experience in clinical operations/development.
- Strong verbal and written communication skills.
- Ability to build and maintain strong relationships within and across functions.
- Experience with Microsoft Office Suite (Word, Excel, Project, Outlook).
- Ability and willingness to travel periodically.
Benefits (USA-based roles):
- Market-leading compensation; 401(k) match; ESPP; pre-tax commuter benefits; referral bonus; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision premiums; HSA + FSA; fertility/family-forming benefits; expanded mental health support; flexible hybrid work; take-what-you-need PTO and company-paid holidays; paid medical and parental leave.
- Execute and manage assigned clinical studies while ensuring Good Clinical Practices (GCP) compliance, high study quality, and timely completion.
- Lead the Clinical Study Team for assigned projects; may lead one or more clinical studies from concept to protocol and achieve milestones (e.g., First Patient In, Interim Analysis, Database lock).
- Manage external vendors and contract research organizations; may manage internal resources such as Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs).
- Prepare/review/approve study documents (e.g., Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, Laboratory Manual).
- Coordinate and design study materials (e.g., CRFs, patient diaries, study participation cards, and source documents).
- Manage operational and monitoring activities at the study level/site level to assure adherence to GCP, SOPs, and study protocols.
- Negotiate and manage vendor work agreements and site contracts.
Qualifications:
- Bachelor’s degree in a scientific discipline or equivalent (advanced degree preferred).
- At least 8 years of biopharma industry experience with relevant clinical trials (biotechnology, pharmaceutical, CRO, or medical device industry), including at least 2 years managing clinical trials.
- Vendor management experience in clinical operations/development.
- Strong verbal and written communication skills.
- Ability to build and maintain strong relationships within and across functions.
- Experience with Microsoft Office Suite (Word, Excel, Project, Outlook).
- Ability and willingness to travel periodically.
Benefits (USA-based roles):
- Market-leading compensation; 401(k) match; ESPP; pre-tax commuter benefits; referral bonus; subsidized lunch/parking.
- 100% employer-paid medical/dental/vision premiums; HSA + FSA; fertility/family-forming benefits; expanded mental health support; flexible hybrid work; take-what-you-need PTO and company-paid holidays; paid medical and parental leave.