Clinical Operations Manager

Position Overview
Clinical Operations is responsible for the global execution of Phase I-IV clinical trials across a range of therapeutic areas. The function ensures that all studies are conducted in compliance with applicable standard operating procedures (SOPs), internal policies, and regulatory requirements, delivering high-quality data to support product registration and commercialization worldwide.

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.

Key Responsibilities

• Oversee all aspects of smaller clinical studies, including Phase I trials.

• Support the selection of contract research organisations (CROs) and vendors, and manage their performance and deliverables.

• 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).

• Develop and implement study logistics and clinical study plans.

• Manage timelines, documentation, and communications related to study progress.

• Lead and participate in project meetings with CROs, vendors, and cross-functional stakeholders.

• Contribute to the development of SOPs, tools, and process improvements to enhance operational efficiency.

• Provide input into study protocols, case report forms, informed consent documents, and study-related presentations.

• Ensure oversight of study sites and review regulatory documentation to maintain compliance with protocols, regulations, SOPs, and monitoring plans.

• Present at internal and external meetings, including investigator meetings where required.

• Contribute to the preparation of safety, interim, and final study reports, resolving data discrepancies as needed.

• Identify operational risks and collaborate with colleagues to implement effective solutions, ensuring studies remain on track in terms of scope, budget, and timelines.

• Support onboarding and mentoring of less experienced team members.

• Ensure all work is conducted in accordance with established practices, policies, and regulatory requirements.

Requirements

Education & Experience

• PharmD or PhD with 2+ years of relevant clinical or life sciences experience; OR

• Master's degree with 3+ years of relevant experience; OR

• Bachelor's degree or RN qualification with 5+ years of relevant experience.

• Demonstrated experience in clinical research, including leading or managing smaller studies or project teams.

• Experience working with and managing external vendors or CROs.

• Proven ability to operate at a senior clinical trial management level.

Knowledge & Skills

• Quick learner with the ability to adapt to changing priorities and work across multiple projects.

• Capable of managing study activities across the full lifecycle, from start-up through close-out.

• Strong understanding of clinical study management practices, tools, and methodologies.

• Solid knowledge of protocol requirements and the ability to interpret and communicate them effectively.

• Good understanding of regulatory frameworks, including FDA, EMA, ICH guidelines, and Good Clinical Practice (GCP).

• Familiarity with medical and scientific terminology.

• Strong communication and organisational skills.

• Ability to work effectively in a collaborative, matrixed environment.

• Able to manage multiple tasks and priorities simultaneously.

• Willingness to travel as required.