Sr. Clinical Research Associate/Clinical trial Manager

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines for patients with genetic diseases and cancers with clear genetic drivers. Founded in 2015, the company has built a portfolio of 20+ drug development programs spanning preclinical to late-stage development across multiple therapeutic areas. QED Therapeutics, an affiliate of BridgeBio Pharma, is dedicated to developing targeted treatments for FGFR-driven skeletal dysplasia, focusing on Achondroplasia (ACH) and Hypochondroplasia (HCH).

Responsibilities

Collaborate within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, GCP, SOPs, and applicable regulations; 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; Lead operational management for assigned regions and sites, including site initiation, monitoring performance metrics, identifying and mitigating risks, driving escalations and action-item closure; Lead aspects of vendor management for the CRO and other key vendors (IRT, imaging, central and specialty labs, etc.); Provide oversight of CRO monitors, including reviewing monitoring documentation, evaluating monitor and site performance, and conducting oversight or co-monitoring visits as needed; Contribute to the development and maintenance of study documents under the direction of the study lead; Ensure the Trial Master File is complete, current, accurate, and inspection-ready; Apply ICH E6(R3) Good Clinical Practice principles across study activities; Exercise sound judgment to resolve or seek expert input on protocol, drug, safety, regulatory, and legal questions; Participate in the review and negotiation of site budgets and contracts; Support and participate in Investigator Meetings and other study-related meetings; Promote a collaborative, respectful, quality-focused work environment; Travel as required (up to 20%)

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

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; Career pathing, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching; Annual performance bonus; Company equity