BridgeBio Pharma - Sr. Clinical Research Associate/Clinical trial Manager
Requirements
• 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, 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 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 • At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. 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. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. • $145,000 - $177,000 USD • As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. • For BridgeBio Full-Time U.S Based Roles:
Responsibilities
• 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, 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 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. • 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%). • Where You'll Work • 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.
Benefits
• 401K with 100% employer match on first 3% & 50% on the next 2% • Employee stock purchase program • Referral program with $2,500 award for hired referrals • Health & Wellbeing: • Comprehensive health care with 100% premiums covered - no cost to you and dependents • Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) • Hybrid work model - employees have the autonomy in where and how they do their work • Unlimited flexible paid time off - take the time that you need • Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents • Flex spending accounts & company-provided group term life & disability • Subsidized lunch via Forkable on days worked from our office • Skill Development & Career Paths: • People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility • We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities • At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. 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. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. • $145,000—$177,000 USD • As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. • For BridgeBio Full-Time U.S Based Roles: • 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 • Referral bonus • Subsidized lunch and parking on in-office days • Subsidized lunch and parking • Health & Well-Being • Health & Well-Being • 100% employer-paid medical, dental, and vision premiums for you and your dependents • 100% employer-paid medical, dental, and vision premiums • Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA) • Health Savings Account (HSA) • Flexible Spending Accounts (FSA) • Fertility & family-forming benefits • Expanded mental health support (therapy and coaching resources) • Expanded mental health support • Hybrid work model with flexibility • Hybrid work model • Flexible, “take-what-you-need” paid time off and company-paid holidays • Flexible, “take-what-you-need” paid time off • Comprehensive paid medical and parental leave to care for yourself and your family • Comprehensive paid medical and parental leave • We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
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