Senior Clinical Research Associate / Associate Clinical Trial Manager in at GONDOLABIO SERVICECO INC

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.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or a related field, or equivalent relevant experience.
• 4+ years of clinical research experience in a biotechnology, pharmaceutical, or CRO environment, including CRA and site monitoring experience.
• Experience supporting clinical trials across study start-up, conduct, and closeout; sponsor-side experience preferred.
• Working knowledge of ICH-GCP, applicable clinical research regulations, and the clinical trial process.
• Experience working with clinical sites, CROs, and study vendors.
• Familiarity with common clinical trial systems such as EDC, CTMS, eTMF, IRT, and eCOA.
• Good organizational and project coordination skills with the ability to manage multiple priorities.
• Strong written and verbal communication skills and ability to work effectively with cross-functional and remote teams.
• Detail-oriented, proactive, and able to identify and escalate study issues appropriately.

Remote Work Requirements

• This is a remote position based in the United States. The successful candidate must be able to work effectively and independently in a remote environment while maintaining strong communication and collaboration with internal study teams, CROs, vendors, investigators, and clinical sites across multiple time zones.
• Regular participation in virtual study-team, CRO/vendor, and site meetings will be required.
• Approximately 10-20% travel may be required for sponsor oversight visits, investigator meetings, critical site visits, internal company meetings, and other study-related activities.

No matter your role at GondolaBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first.
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision-both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple GondolaBio programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion

The base pay range for this position is $110,000 to $120,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location.

GondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of BridgeBio and all affiliated companies should work through their managers to inquire about and learn more about this role.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of GondolaBio and make false use of our company name to defraud job seekers. To protect yourself, please note that our official corporate website is https://gondolabio.com/; our careers page is https://gondolabio.com/#careers; our LinkedIn page is https://www.linkedin.com/company/gondolabio/. Please visit these links for official information from GondolaBio. Communication from any other variant is fraudulent. GondolaBio does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without interviews.