Sr. Clinical Research Associate/Clinical trial Manager

Company Overview

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). Achondroplasia is the most common form of genetically driven short stature, and Hypochondroplasia is a genetic condition that affects the way bones grow; both conditions can lead to significant medical complications throughout life. With our investigational therapeutic candidate, infigratinib, we seek to deliver meaningful treatment options that address the underlying cause of these conditions and improve outcomes for children and families living with ACH and HCH.

What You’ll Do

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.
• 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%).

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.

• Who You Are
• 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