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Senior Clinical Trial Manager
BridgeBioSenior Clinical Trial Manager overseeing clinical studies in biopharmaceutical innovation. Leading cross-functional teams to ensure compliance and timely completion of projects.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
clinical study managementclinical trial designGCPSOPssource data verificationvendor managementclinical monitoringstudy document preparationproject managementbiopharma industry experience
Soft Skills
strong communication skillsrelationship buildingstrategic direction communicationcross-functional collaborationleadershiporganizational skillsproblem-solvingteam managementnegotiation skillsadaptability
Tools & Technologies
Microsoft Office Suiteclinical research softwaredata management systemsproject management toolselectronic data capture systemsclinical trial management systemsstatistical analysis softwarelaboratory information management systemsvendor management systemsdocument management systems
Industry Keywords
clinical trialsbiotechnologypharmaceuticalCROmedical deviceFirst Patient InInterim AnalysisDatabase lockclinical research associatesclinical trial assistants
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Leads the Clinical Study Team for assigned projects; may lead one or more clinical studies, from concept to protocol, and achieve corporate objectives and key milestones such as First Patient In, Interim Analysis, Database lock, etc.
- 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 such as the Monitoring Manual, Study Operational Manual, Source Data Verifications Plan, and Laboratory Manual
- Coordinate and design study materials such as CRFs, patient diaries, study participation cards, and source documents.
- Manage operational activities at the study level and monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to GCP, Standard Operating Procedures (SOPs), and study protocols
- Negotiate and manage vendor work agreements and site contracts
Requirements
What you’ll need- Bachelor’s degree in a scientific discipline or equivalent is required, and an advanced degree is preferred
- Requires at least eight years of biopharma industry experience (relevant clinical trials experience, in the biotechnology, pharmaceutical, CRO, medical device industry) with at least two years managing clinical trials.
- Must have vendor management experience in clinical operations/development
- Strong verbal and written communication skills, can communicate strategic direction and relevant context so that employees at all levels understand their role in achieving success
- Ability to build and maintain strong working relationships within the department and cross- functionally to meet a project or corporate goal
- Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook)
- Must be able and willing to travel periodically
Benefits
Comp & perks- Market-leading compensation
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Hybrid work model with flexibility
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave to care for yourself and your family