Clinical Trial Manager (CTM)

Orna Therapeutics is an innovative biotechnology startup based in Watertown, MA, committed to developing groundbreaking therapies for diseases that current approaches cannot address. With our pioneering circular RNA technology, developed at MIT, we are at the forefront of advancing the next generation of RNA therapeutics. Our state-of-the-art expression and delivery platform positions us to tackle complex diseases, including B cell-driven autoimmune disorders, B cell malignancies, sickle cell disease, and beyond.

We are seeking a Clinical Trial Manager (CTM) to join our lean, high-performing Clinical Operations team. Reporting to the Senior Director of Clinical Operations, the CTM will be responsible for managing day-to-day clinical trial activities across one or more global studies. This is a hands-on role requiring operational expertise, collaborative spirit, and the ability to thrive in a fast-paced, dynamic environment.

Responsibilities

• Study-level leadership and oversight of one or more global clinical trials (Phase I to III) in collaboration with external vendors, for activities from study inception through closure.
• Manage CROs, vendors, and site relationships to ensure quality execution and compliance with study protocols.
• Serve as primary contact for the clinical study vendors and functional area representatives involved with the trial execution.
• Manage CROs and other clinical study vendors to ensure studies are completed within agreed upon timelines, budget, and quality. Must be comfortable with taking on additional study responsibilities when needed (for example, co-monitoring... etc.).
• Partner with internal cross-functional stakeholders to ensure alignment on trial timelines, deliverables, and milestones.
• Perform timely and thorough review of monitoring reports, progress reports and other associated deliverables of external clinical vendors to demonstrate sponsor oversight.
• Monitor trial progress, identify risks, and develop mitigation strategies in collaboration with external clinical vendors and internal stakeholders.
• Contribute to the preparation and management of clinical trial budgets, timelines, review and approval of vendor plus other applicable invoices.
• Support the development and review of key clinical documents (e.g., protocols, ICFs, manuals, CSR) and clinical study plans.
• Lead or support site selection, start-up, enrollment tracking, monitoring oversight, and closeout activities.
• Participate in the review of study data and ensure data integrity and timely query resolution.
• Partner with clinical investigators, site staff, patient advocacy groups to build healthy Site-Sponsor relationship and ensure study goals are met.
• Contribute to SOP development and process optimization within the Clinical Operations function
• Other duties as assigned.

Qualifications

• Bachelor's degree in life sciences or related field (advanced degree a plus).
• 5+ years (8+ years will be considered for Senior CTM) of clinical trial management experience in biotech/pharma, including autoimmune/rheumatology and first-in-human studies.
• Autonomously managed and completed at least 1 (at least 2 for Senior CTM) multi-country clinical trial from start-up through closure.
• Demonstrated ability to lead studies independently, preferably in a startup or small team environment.
• Direct CRO and vendor management experience is required, including performance oversight and issue resolution.
• Working knowledge of FDA, ICH-GCP, and international regulatory requirements.
• Prior involvement in IND or EU CTR submissions.
• Proficiency in common CTMS, eTMF, and EDC systems.
• Strong communication, problem-solving, and organizational skills.

Preferred Experience

• Autoimmune therapeutic area experience.
• Experience in early-phase studies and adaptive trial designs.

Why Orna?

At Orna Therapeutics, we're more than just a workplace-we're a community. We believe in fostering an environment where individuals can grow, thrive, and make a lasting impact on the future of healthcare. Join us as we revolutionize RNA therapeutics and make a difference in the lives of patients around the world.

Equal Employment Opportunity Statement

Individuals seeking employment at Orna Therapeutics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.