[Hiring] Senior Clinical Research Associate/Clinical Trial Manager @BridgeBio Pharma

Role Description

As a Sr. Clinical Research Associate/Clinical Trial Manager, you will collaborate within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, GCP, SOPs, and applicable regulations. You will be responsible for performing quality study oversight processes, including:

• Monitoring communications with site staff and clinical vendors
• Reviewing monitoring trip reports

Key responsibilities include:

• Partnering with the Clinical Operations Study Lead and cross-functional team to support clinical studies from planning and start-up through execution, maintenance, and close-out.
• Leading operational management for assigned regions and sites by driving site initiation activities, monitoring performance metrics, identifying and mitigating risks, and representing regional performance in study team discussions.
• Managing vendor relationships for the CRO and other key vendors, ensuring deliverables are met and performance measures are maintained.
• Providing oversight of CRO monitors and conducting oversight or co-monitoring visits as needed.
• Contributing to the development and maintenance of study documents under the direction of the study lead.
• Ensuring the Trial Master File is complete, current, accurate, and inspection-ready.
• Applying ICH E6(R3) Good Clinical Practice principles across study activities.
• Participating in the review and negotiation of site budgets and contracts.
• Supporting and participating in Investigator Meetings and other study-related meetings.
• Promoting a collaborative, respectful, quality-focused work environment.
• Traveling as required to carry out responsibilities (up to 20%).

Qualifications

• Bachelor’s degree or equivalent training and experience (i.e., RN/PA, BSN degree) in a scientific or medical field.
• Minimum 4-6 years of clinical study experience, preferably within biotechnology or pharmaceutical sponsor organization.
• Experience supporting global studies in a fast-paced environment.
• Success in working with CROs and vendors; must have vendor management experience in Clinical Operations.
• Excellent communication skills and ability to achieve milestones in a team environment.
• Ability to communicate and collaborate respectfully in a remote environment.
• Ability to build and maintain strong working relationships within the department, cross-functionally, with clinical sites, vendors, and CROs.
• Working knowledge of ICH E6(R3) Good Clinical Practice principles and risk-based quality management.
• Experience using M.S. Office Suite (Excel, Word, PowerPoint) and SmartSheet.

Requirements

• Travel as required to carry out responsibilities (up to 20%).

Benefits

• 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
• Career pathing through regular feedback, continuous education and professional development programs
• Celebration of strong performance with financial rewards, peer-to-peer recognition, and growth opportunities