Senior Clinical Research Associate / Associate Clinical Trial Manager

Job not on LinkedIn

🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $110k - $120k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 4%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Support day-to-day management of clinical studies from start-up through enrollment, conduct, database lock, and closeout • Manage assigned studies or defined operational components under Clinical Trial Manager or Clinical Operations Lead direction • Develop, maintain, and track study timelines, milestones, risks, issues, and action items • Coordinate activities across internal functions, CROs, vendors, and clinical sites • Identify operational risks and support mitigation and escalation plans • Prepare study team meetings, status updates, and operational metrics • Serve as operational point of contact for assigned CROs, vendors, and clinical sites • Provide sponsor oversight of CROs, vendors, clinical sites, and monitoring activities • Participate in CRO and vendor selection, proposal review, RFP evaluation, and bid-defense activities • Monitor CRO/vendor performance, study metrics, risks, issues, deliverables, budgets, invoices, forecasts, and financial tracking • Support site feasibility, activation, monitoring follow-up, issue resolution, and sponsor oversight visits • Coordinate investigational product distribution, study supplies, biological sample logistics, and laboratory sample tracking • Develop, review, and maintain clinical study documents, plans, tools, workflows, and site-facing materials • Collaborate with Data Management on CRF review, data review, data cleaning, and quality metrics • Support EDC, IRT, CTMS, eTMF, and eCOA systems and review study/site metrics • Support regulatory and IRB/IEC submissions and compliance with protocol, ICH-GCP, regulations, and company procedures • Maintain sponsor oversight of the Trial Master File and support audits, protocol deviation follow-up, compliance activities, and CAPAs

🎯 Requirements

• 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 EDC, CTMS, eTMF, IRT, and eCOA • Good organizational and project coordination skills with 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 • Must be based in the United States • Ability to work independently in a remote environment across multiple time zones • Ability to travel approximately 10–20%

🏖️ Benefits

• Patient Days • Learning and development resources • 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 • Decentralized model with decision-making power close to the science • Collaborative, fast-paced, data-driven environment

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume