Senior Clinical Trial Manager – Oncology

This is a fully remote position, open to applicants in Europe.

📋 Description

• Oversee and coordinate clinical site management activities from the initiation of the study through to database lock and study closure.

• Collaborate with project management to create monitoring strategies, set site management objectives, and ensure project goals are met.

• Provide leadership, direction, and support to CRAs and site management personnel throughout assigned studies and regions.

• Act as the primary site management liaison for sponsors, study teams, investigator meetings, audits, inspections, and crucial project discussions.

• Ensure quality and compliance by supervising monitoring activities, assessing protocol deviations, guaranteeing adherence to Clinical Monitoring Plans, and maintaining readiness for inspections.

• Track study metrics, recruitment effectiveness, resource distribution, and operational trends to identify risks and implement appropriate solutions.

• Assist in patient recruitment initiatives by monitoring enrollment progress and advising on site-specific recruitment strategies.

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

• Identify, escalate, and mitigate operational and monitoring risks while facilitating issue resolution and promoting continuous improvement.

• Work in collaboration with project management, sponsors, CRAs, and cross-functional teams across various time zones.

⛳️ Requirements

• Bachelor’s degree or equivalent with a major focus in biological, physical, or health studies, along with a minimum of 4 years of experience as a Senior Clinical Research Associate (or equivalent), OR

• Associate degree or equivalent education/training and at least 6 years of experience as a Senior Clinical Research Associate, PLUS a minimum of 2 years of relevant experience as a CTM/LCRA (or equivalent), which includes supervising a CTM team.

• A nursing degree or equivalent life sciences degree is preferred.

• Experience with Oncology studies is mandatory.

• Proven track record in leading or coordinating clinical monitoring and site management tasks within clinical trials.

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

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

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

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

• Ability to lead and inspire remote teams, influence stakeholders, solve intricate problems, and manage multiple priorities.

• Proficiency in English, with exceptional written, verbal, presentation, and interpersonal communication abilities.

🏝️ Benefits

• Equal employment opportunities.

• A diverse and inclusive work environment.

• Accessible and hands-on leadership.

• Supportive and cohesive teams.

• Opportunities for professional growth and success enablement.

• Remote work arrangement.

• Travel as needed.