Senior Clinical Research Associate / Associate Clinical Trial Manager

About GondolaBio

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.?

Position Summary

We are seeking an experienced and highly collaborative Senior Clinical Research Associate / Associate Clinical Trial Manager (Sr. CRA / Associate CTM) to join our Clinical Operations team in a sponsor-side role.

This position will support the planning, execution, oversight, and delivery of clinical trials from study start-up through closeout. The role combines strong clinical monitoring and site-management expertise with increasing responsibility for study-level operational management.

The Sr. CRA / Associate CTM will work closely with Clinical Operations leadership, Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Pharmacovigilance/Safety, Clinical Supply, Quality, CROs, vendors, investigators, and clinical sites to ensure studies are delivered on time and in compliance with the protocol, ICH-GCP, applicable regulations, and company procedures. This person will report to the Sr. Director Clinical Operations.

The individual may independently manage defined study components, vendors, countries, or specific parts of studies.

Key Responsibilities

Study Management

• Support day-to-day management of clinical studies from start-up through enrollment, study conduct, database lock, and closeout.
• Manage assigned studies or defined operational components of larger clinical trials under the direction of the Clinical Trial Manager or Clinical Operations Lead.
• Develop, maintain, and track study timelines, milestones, risks, issues, and action items.
• Coordinate activities across internal functions, CROs, vendors, and clinical sites to ensure timely completion of study deliverables.
• Proactively identify operational risks and support development of appropriate mitigation and escalation plans.
• Prepare and contribute to study team meetings, study status updates, and operational metrics.
• Serve as an operational point of contact for assigned CROs, vendors, and clinical sites.

CRO & Vendor Oversight

• Provide sponsor oversight of CROs and external vendors.
• Participate in CRO and vendor selection, including proposal review, RFP evaluation, and bid-defense activities.
• Monitor CRO and vendor performance against timelines, quality expectations, contracts, and agreed deliverables.
• Review study metrics, risks, issues, and action items with CRO and vendor partners and support timely resolution.
• Assist with vendor budgets, change orders, invoices, forecasts, and financial tracking.

Site Management, Monitoring & Study Supplies

• Provide sponsor oversight of clinical sites and CRO/field monitoring activities, including site feasibility, activation, monitoring follow-up, and resolution of site issues.
• Review monitoring reports, track key findings and protocol deviations, and support remote or on-site sponsor oversight activities as needed.
• Collaborate with Clinical Supply/CMC, CROs, vendors, central laboratories, and sites to support investigational product distribution and accountability, study supplies, biological sample logistics, and tracking of laboratory samples and other study-specific endpoints.

Study Documentation & Operational Support

• Contribute to the development, review, and maintenance of key clinical study documents, plans, tools, and site-facing materials.
• Support study execution and implementation of study processes and workflows as needed.

Data & Clinical Systems

• Collaborate with Data Management to support timely, high-quality clinical data, including CRF review, data review, data-cleaning activities, and study-specific quality metrics.
• Support the use of clinical systems such as EDC, IRT, CTMS, eTMF, and eCOA and review study/site metrics to identify operational issues and trends.

Regulatory, Quality & TMF

• Support regulatory and IRB/IEC submissions and help ensure study activities are conducted in accordance with the protocol, ICH-GCP, applicable regulations, and company procedures.
• Support maintenance and sponsor oversight of the Trial Master File (TMF), including document completeness, quality checks, and inspection readiness.
• Work with Clinical Quality and study teams to support audits, protocol deviation follow-up, compliance activities, and CAPAs as needed.