Sr. Clinical Research Associate/Clinical Trial Manager

BridgeBio
San Francisco
Workplace: RemoteFull timeUSD 135,000 - 177,000 annuallyFunction: Research & Scientific (R&D)Experience: 4-6 yearsEducation: bachelorsSkills: ["Communication","Risk management","Cross-functional collaboration","Vendor management","Judgment"]

Collaborate with the Clinical Operations team to oversee the timely execution of clinical studies according to protocols, GCP, SOPs, and regulations. Partner with study leads to manage regions and sites, serve as primary contact for investigators and sites, and lead vendor and CRO oversight. Maintain inspection-ready Trial Master Files, manage study tracking metrics, support key study documents, and contribute to budgets, contracts, and investigator meetings while applying ICH E6(R3) quality-by-design principles.

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FursaFursa
BridgeBio
BridgeBio
1 day ago

Sr. Clinical Research Associate/Clinical Trial Manager

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Job Summary

Collaborate with the Clinical Operations team to oversee the timely execution of clinical studies according to protocols, GCP, SOPs, and regulations. Partner with study leads to manage regions and sites, serve as primary contact for investigators and sites, and lead vendor and CRO oversight. Maintain inspection-ready Trial Master Files, manage study tracking metrics, support key study documents, and contribute to budgets, contracts, and investigator meetings while applying ICH E6(R3) quality-by-design principles.
Location: San Francisco
Workplace: Remote
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Support clinical studies from planning and start-up through execution, maintenance, and close-out in accordance with assigned SOPs, ICH/GCP, and goals.
  • •Lead operational management for assigned regions and sites by monitoring performance metrics, identifying/mitigating risks, driving escalations, and closing action items.
  • •Serve as primary sponsor contact for assigned investigators and study sites, ensuring effective communication and issue resolution.
  • •Oversee CRO monitors by reviewing monitoring documentation, evaluating performance, and conducting oversight/co-monitoring visits as needed to identify cross-site risks.
  • •Maintain and analyze study tracking tools and operational metrics, ensure Trial Master File readiness, and develop/maintain key study documents under the study lead.
Travel: Medium travel

Pay and Benefits

Salary: USD 135,000 - 177,000 annually
Equity and Bonus:Equity
Perks:401kEquityEsppHealth InsuranceDentalVisionHsaFsaPaid LeaveParental Leave

Key Requirements

  • •4-6 years of clinical study experience.
  • •Experience supporting global clinical studies in a fast-paced environment.
  • •Track record of working with CROs and vendors to achieve milestones.
  • •Strong communication and ability to collaborate respectfully in a remote environment.
  • •Knowledge of ICH E6(R3) Good Clinical Practice and risk-based quality management, with experience overseeing Trial Master Files and monitoring activities (site initiation, interim monitoring, close-out).
Experience:4-6 yearsBiotechnologyPharmaceuticals
Education:Bachelor's
Skills:CommunicationRisk managementCross-functional collaborationVendor managementJudgment
Languages:English
Tech Stack:ICH E6(R3) Good Clinical PracticeGCPSOPsSmartSheetM.S. Office SuiteExcelWordPowerPointTrial Master FileCRFs

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn