Senior Clinical Trial Manager - Oncology (Europe)

• Lead and coordinate clinical site management activities from study startup through database lock and study closeout.

• Partner with project management to develop monitoring strategies, establish site management targets, and ensure delivery against project goals.

• Provide leadership, guidance, and oversight to CRAs and site management team members across assigned studies and regions.

• Serve as the primary site management representative for sponsors, study teams, investigator meetings, audits, inspections, and key project discussions.

• Drive quality and compliance by overseeing monitoring activities, reviewing protocol deviations, ensuring adherence to Clinical Monitoring Plans, and maintaining inspection readiness.

• Monitor study metrics, recruitment performance, resource allocation, and operational trends to identify risks and implement effective solutions.

• Support patient recruitment efforts by tracking enrollment progress and guiding site-specific recruitment strategies to maintain study targets.

• Ensure Trial Master File compliance and oversee the timely completion and quality review of site management documentation.

• Proactively identify, escalate, and mitigate operational and monitoring risks while supporting issue resolution and continuous improvement initiatives.

• Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of 4 years as a Senior Clinical Research Associate (or equivalent), OR
• Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of 6 years as a Senior Clinical Research Associate, AND

•

relevant experience as a CTM/LCRA (or equivalent) including overseeing a CTM team.

• Experience working with

is required for this role.

• Experience leading or coordinating clinical monitoring and site management activities within clinical trials.

• Strong understanding of clinical research principles, site management processes, and monitoring best practices.

• Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and clinical trial SOPs.

• Experience reviewing study metrics, managing operational risks, supporting recruitment activities, and maintaining high-quality study documentation.

• Proficiency with Microsoft Office and clinical systems including EDC, CTMS, IxRS/IVRS, and eCRF platforms.

• Demonstrated ability to lead and motivate remote teams, influence stakeholders, solve complex problems, and manage multiple priorities effectively.

• Proficiency in English, with excellent written, verbal, presentation, and interpersonal communication skills.

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