Senior Clinical Trial Manager, Clinical Operations – EU
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Job Description
Senior Clinical Trial Manager leading clinical operations for oncology studies with a focus on end-to-end trial management. Remote position within a growth-stage biotech company.
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 escalate 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
Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or related scientific discipline required; with 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, with experience overseeing multi-regional, multi-site studies and global CRO partners
- Experience in oncology clinical trials required; 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:
- company paid healthcare
- flexible spending accounts
- voluntary life insurance
- 401K matching
- uncapped vacation
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