Role Description
The Senior Clinical Trial Manager and Clinical Trial Manager profile is responsible for the end-to-end operational oversight of assigned clinical trials, ensuring delivery against agreed timelines, budget, and quality standards. This includes oversight of site management (remote and onsite), clinical team activities, and compliance with regulatory requirements.
Sr CTM and CTM roles lead Clinical Operations execution and serve as the primary point of accountability for trial delivery, working cross-functionally with internal teams and externally with sponsors.
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Trial Execution & Oversight
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Plan and manage all clinical operations activities across assigned trials.
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Ensure delivery in line with scope, timelines, budget, and quality expectations.
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Oversee site lifecycle activities, including start-up, activation, monitoring, and close-out.
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Team Leadership & Oversight
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Lead and oversee project specific operational activities of Clinical Research Associates (CRAs) and Site Management Associates (SMAs).
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Provide direction, training, and study performance oversight for clinical team members.
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Review monitoring reports, documentation, and study deliverables for quality and compliance.
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May act as a mentor to study assigned CRAs, SMAs, and/or other department CTMs.
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Site & Monitoring Management
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Develop and implement site management and monitoring plans.
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Oversee remote and onsite monitoring activities, including visit planning and execution.
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Ensure timely collection, review, and maintenance of trial documentation in CTMS.
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Stakeholder Management
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Collaborate with cross-functional teams (Project Management, Data Management, Finance).
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Build and maintain strong relationships with sponsors and external partners.
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Provide status updates, metrics, and key study insights to stakeholders.
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Compliance & Governance
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Ensure adherence to ICH-GCP, regulatory requirements, and internal SOPs.
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Support audit and inspection readiness.
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Additional Contributions
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Participate in bid defense activities as required.
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Contribute to department initiatives, process improvements and operational best practices.
Qualifications
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Bachelor’s degree in life sciences or related field (or equivalent experience) with at least 1+ year of experience in a CTM or equivalent role (CRO or pharmaceutical environment) (CTM)
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Bachelor’s degree in life sciences or related field (or equivalent experience) with at least 3+ years of experience in a CTM or equivalent role (CRO or pharmaceutical environment) (Sr CTM)
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Experience managing Phase III and/or IV clinical trials across multiple therapeutic areas.
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Knowledge of risk-based monitoring (RBM) principles preferred.
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Experience managing North American studies.
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Ability to manage multiple studies and priorities in a fast-paced environment.
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Strong leadership, organizational, and problem-solving skills.
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Effective communication and stakeholder management skills.
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Willingness to travel (~15%).
Benefits
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Competitive base salary and performance related incentives.
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Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
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Retirement and pension plans.
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Life assurance and disability coverage.
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Employee assistance programmes and wellbeing resources.
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Learning and development opportunities through structured training and career pathways.
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Benefits may vary depending on role and location.