Job Summary
The Senior Clinical Trial Manager, Clinical Operations, serves as the operational lead for assigned early-phase oncology studies, providing end-to-end trial leadership from start‑up through close‑out. In close partnership with Clinical Development, Regulatory, Biometrics, and external CROs, the role drives high‑quality, inspection‑ready trial execution within a collaborative, growth‑stage biotech environment. The Senior CTM is accountable for vendor oversight, risk management, timeline and budget performance, and cross‑functional alignment to ensure studies are delivered efficiently and in compliance with global regulatory requirements. The senior manager has primary responsibility for international regions including Europe, Asia‑Pacific, and the United Kingdom, and secondary oversight of North America. This position reports to the Director of Clinical Operations and is remote in the EU or UK.
Key Responsibilities
* Provide end‑to‑end operational leadership for complex, multi‑regional clinical trials from start‑up through close‑out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs.
* Lead cross‑functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners.
* Develop and execute enrollment, site management, and monitoring strategies to ensure high‑quality trial conduct and performance.
* Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support.
* Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution.
* Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials.
* Lead study‑related training for investigators, site personnel, and internal teams.
* Proactively identify, assess, and elevate operational risks with mitigation strategies and clear recommendations.
* Mentor and support junior clinical operations staff, including potential dotted‑line management responsibilities.
* Travel up to 10–20% to support regional study oversight and site engagement.
Qualifications
* Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related scientific discipline; 7+ years of progressive clinical trial management experience in biotech, pharmaceutical, and/or CRO environments.
* Demonstrated expertise managing clinical trials from start‑up through close‑out, overseeing multi‑regional, multi‑site studies and global CRO partners.
* Experience in oncology clinical trials, with solid tumor and early‑phase (Phase I/Ib or II) experience preferred.
* Strong knowledge of EU Clinical Trial Regulation (EU CTR 536/2014), ICH‑GCP (E6 R2/R3), GDPR, and applicable local regulatory requirements across EU member states.
* Experience with clinical trial submissions via CTIS and coordination with Ethics Committees and Competent Authorities.
* Excellent written and verbal communication skills in English; additional EU languages are a plus.
* Proficiency with clinical trial systems, including CTMS, eTMF platforms, IRT systems, EDC systems, and safety databases.
* Ability to thrive in a collaborative, fast‑paced, growth‑stage biotech environment with evolving priorities and high accountability.
Benefits
We offer industry‑leading competitive pay, company‑paid healthcare, flexible spending accounts, voluntary life insurance, 401(k) matching, and uncapped vacation.
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