[Remote] Sr. Clinical Research Associate/Clinical trial Manager

Note: The job is a remote job and is open to candidates in USA. BridgeBio is a biopharmaceutical company developing transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. The Senior Clinical Research Associate/Clinical Trial Manager will support clinical studies from planning through close-out, oversee sites and CROs, manage vendors, ensure study documentation and trial quality, and help maintain compliance with protocols, GCP, SOPs, and applicable regulations.

Responsibilities

• 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 driving site initiation activities, monitoring performance metrics, identifying and mitigating risks, driving escalations and action-item closure, and representing regional performance in study team and cross-functional discussions
• 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
• 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
• 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
• Exercises sound judgment to resolve or, as appropriate, seek expert input on protocol and drug questions, safety, regulatory, and legal questions
• Participates 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
• Additional Clinical Operations activities may be assigned as appropriate
• Travel as required to carry out responsibilities (up to 20%)

Skills

• Hold a 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
• 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 to meet a project or corporate goal
• 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
• Preferably within biotechnology or pharmaceutical sponsor organization

Benefits

• An annual performance bonus
• Company equity
• 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
• 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
• Financial rewards, peer-to-peer recognition, and growth opportunities

Company Overview

Company H1B Sponsorship