Clinical Trial Manager

About Celea Therapeutics

Celea Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” our name reflects our mission to rise above the status quo and deliver therapies that change lives. Our lead program, deupirfenidone (LYT-100), is currently in Phase 3 clinical development with active candidate enrollment, representing a potential new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.

Rising above the status quo takes a team as strong as its science, and we hire and work by five values:
accountability — owning outcomes and acting like owners;
transparency — talking straight and building trust;
collaboration — achieving together what no one could alone;
innovation — challenging accepted ideas and taking smart risks; and passion — bringing energy and heart to the mission.

As we prepare for our next stage of growth and clinical advancement, Celea is seeking a highly motivated, goal-oriented, and hands‑on Clinical Trial Manager (CTM) to execute late‑stage global clinical trials and help build our Clinical Operations team. Reporting to the Vice President of Clinical Operations, this role will oversee the clinical aspects of assigned studies — including timelines, vendor management, and study quality — while also working hands‑on with a highly collaborative cross‑functional team.

In this highly visible role, you will have exposure to our senior leaders, be integral in the decision‑making process, and be at the forefront of scientific innovation and business growth.

In the near term, the focus will be executing our late‑stage global clinical trial(s) with excellence — keeping timelines, quality, and vendor deliverables on track. Over time, this person will help strengthen the processes and operational infrastructure that will carry Celea through its next stage of growth, and will be instrumental in guiding Celea through its next chapter.

This position is remote or hybrid friendly
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• 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.

• 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…