Note: The job is a remote job and is open to candidates in USA. Celea Therapeutics is a biotechnology company advancing transformative treatments for serious respiratory diseases. The Clinical Trial Manager will independently oversee late-stage global clinical trials, managing timelines, vendors, study quality, compliance, data reviews, and cross-functional execution while helping build clinical operations infrastructure.
Responsibilities
- Independently oversee all clinical aspects of the study (for trial region, if applicable): assess operational feasibility, recommend study execution plans, and manage study timelines and metrics
- Oversee CROs and external vendors — participate in vendor selection, develop vendor specifications, and review vendor deliverables, budgets, and metrics
- Lead study execution: provide study-specific training and leadership to clinical research staff (including CRO, CRAs, sites, and other contract personnel); plan and manage study-specific meetings; participate in site monitoring visits as appropriate; and prepare and present project debriefings as required
- Optimize trial design and execution — work with the study team to design clinical trial protocols, develop and manage an ongoing data review plan to detect data trends, and prepare or review study-related documents (e.g., ICF template, CRFs, Monitoring Plan, Laboratory Manual, Pharmacy Manual, CRF Completion Guidelines)
- Partner cross-functionally with the Medical Monitor, Regulatory Affairs, CRO, vendors, and investigators/site staff; assist in the development and escalation of site budgets
- Ensure all clinical trials are executed in compliance with ICH/GCP guidelines, applicable regulations, and SOPs: plan quality assurance activities, coordinate resolution of audit findings, review monitoring reports, and maintain an audit-ready, inspection-ready eTMF
- Coordinate and participate in data reviews with CRO/Data Management staff, and support submissions to regulatory authorities or IRB/ethics committees, including query responses
- Participate in the selection, training, and evaluation of study personnel (contract and internal), support review and revision of departmental SOPs, and help establish and maintain operational infrastructure
Skills
- BS/BA/RN degree in a life science or health-related field preferred; equivalent experience considered
- 5+ years of experience managing global clinical studies, with a strong understanding of global clinical trial operations
- Strong working knowledge of FDA Regulations and GCP/ICH guidelines, and experience managing CROs, vendors, and/or clinical trial consultants
- Demonstrated ability to independently lead and manage multiple projects simultaneously, prioritize workload, meet deliverable timelines, exercise managerial discretion, apply advanced analytical/forward-thinking skills, and escalate when necessary
- Entrepreneurial mindset and comfort operating in a fast-paced, early-stage environment
- Experience working in the therapeutic area of respiratory therapy
- CRA experience performing onsite monitoring visits
- Proficiency using AI tools to work smarter — curiosity about how technology can improve the quality and speed of your work
Benefits
- Remote or hybrid friendly
- Competitive compensation and equity package.
- Bonus and equity compensation
Company Overview