In this role, you will oversee clinical studies within assigned geographic region(s) or manage specific components of larger programs. Typically, this includes responsibility for Phase I or other smaller-scale studies. You will contribute to study planning, logistics, and execution to ensure objectives are achieved, and may also support broader strategic initiatives.
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Oversee all aspects of smaller clinical studies, including Phase I trials.
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Support the selection of contract research organisations (CROs) and vendors, and manage their performance and deliverables.
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Act as the primary operational contact for assigned studies, ensuring appropriate oversight of site evaluation, initiation, monitoring, and close-out activities (directly or via CROs).
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Develop and implement study logistics and clinical study plans.
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Manage timelines, documentation, and communications related to study progress.
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Lead and participate in project meetings with CROs, vendors, and cross-functional stakeholders.
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Contribute to the development of SOPs, tools, and process improvements to enhance operational efficiency.
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Provide input into study protocols, case report forms, informed consent documents, and study-related presentations.
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Ensure oversight of study sites and review regulatory documentation to maintain compliance with protocols, regulations, SOPs, and monitoring plans.
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Present at internal and external meetings, including investigator meetings where required.
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Contribute to the preparation of safety, interim, and final study reports, resolving data discrepancies as needed.
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Identify operational risks and collaborate with colleagues to implement effective solutions, ensuring studies remain on track in terms of scope, budget, and timelines.
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Support onboarding and mentoring of less experienced team members.
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Ensure all work is conducted in accordance with established practices, policies, and regulatory requirements.
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Quick learner with the ability to adapt to changing priorities and work across multiple projects.
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Capable of managing study activities across the full lifecycle, from start-up through close-out.
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Strong understanding of clinical study management practices, tools, and methodologies.
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Solid knowledge of protocol requirements and the ability to interpret and communicate them effectively.
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Good understanding of regulatory frameworks, including FDA, EMA, ICH guidelines, and Good Clinical Practice (GCP).
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Familiarity with medical and scientific terminology.
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Strong communication and organisational skills.
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Ability to work effectively in a collaborative, matrixed environment.
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Able to manage multiple tasks and priorities simultaneously.
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Willingness to travel as required.
