Sr. Clinical Research Associate/Clinical Trial Manager

About the role

Reporting to the Sr. Director, Clinical Operations, the Sr. Clinical Research Associate/Clinical Trial Manager collaborates within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, GCP, SOPs, and applicable regulations. We build bridges to groundbreaking advancements in rare disease and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry.

At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Responsibilities

• Perform quality study oversight processes, including monitoring communications with site staff and clinical vendors, and reviewing monitoring trip reports.
• Partner 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 in accordance with assigned SOPs, ICH/GCP, and corporate and departmental goals.
• Lead operational management for assigned regions and sites by monitoring performance metrics, identifying and mitigating risks, driving escalations and action-item closure, and representing regional performance in study team and cross-functional discussions.
• Serve as the primary sponsor contact for assigned investigators and study sites, building strong relationships and supporting effective communication and issue resolution.
• Lead aspects of vendor management for the CRO and other key vendors (IRT, imaging, central and specialty labs, etc.), establishing expectations, ensuring deliverables are met, performance measures are maintained, and escalating as needed; address performance gaps and drive corrective actions to closure.
• Provide oversight of CRO monitors by reviewing monitoring documentation, evaluating monitor and site performance, conducting oversight or co-monitoring visits as needed, and identifying cross-site or systemic risks.
• Maintain and analyze study tracking tools and operational metrics, including site start-up, screening, enrollment, study visits, data entry, query resolution, and monitoring activities.
• Contribute to the development and maintenance of study documents, including informed consent forms, site training materials, CRFs, monitoring plans, source document templates, protocols, investigator brochures, and regulatory submission materials under the direction of the study lead.
• Ensure the Trial Master File is complete, current, accurate, and inspection-ready, and drive resolution of missing or deficient documentation.
• Assist with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
• Apply ICH E6(R3) Good Clinical Practice principles, including quality by design, risk-proportionate oversight, critical-to-quality factors, participant protection, and reliable trial results, across study activities.
• Escalate concerns regarding timelines, milestones, resourcing, and any potential study execution issues to the Study Lead.
• Exercise sound judgment to resolve or, as appropriate, seek expert input on protocol and drug questions, safety, regulatory, and legal questions.
• Oversee operational study needs, including clinical supplies.
• Participate in the review and negotiation of site budgets and contracts.
• Support and participate in Investigator Meetings and other study-related meetings, as required.
• Promote a collaborative, respectful, quality-focused work environment.
• Travel as required to carry out responsibilities (up to 20%).

Requirements

• Bachelor's degree or equivalent training and experience (i.e., RN/PA, BSN degree).
• Minimum 4-6 years of clinical study experience.

Skills

• Experience supporting global studies in a fast-paced environment.
• Success in working with CROs and vendors.
• Excellent communication skills and ability to achieve milestones in a team environment.
• Ability to communicate and collaborate respectfully in a remote environment.

Preferred Qualifications

• Experience working within a biotechnology or pharmaceutical sponsor organization.
• Prior experience as a monitoring Clinical Research Associate, including site initiation, interim monitoring, and close-out visits.
• Experience maintaining or overseeing Trial Master Files, including document completeness, quality, timeliness, and inspection readiness.
• 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.

Where You'll Work

This is a U.S.-based remote role that will require quarterly, or as needed, visits to our San Francisco Office.

Pay

Salary: $135,000 - $177,000 USD

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, educational background, location of residence, and performance during the interview process.

Benefits

• Financial & Rewards
  • 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.
• Health & Well-Being
  • 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.
• Skill Development & Career Paths
  • People are part of our growth and success story—endless opportunities for skill development and internal mobility.
  • Career pathing through regular feedback, continuous education, and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching.
  • Celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.