Associate Director, Country Operations Management

Associate Director, Country Operations Management

As Associate Director, Country Operations Management (AD COM), you will report to the Director, Study Start‑Up and Site Partnership and play a central role in implementing the country strategy. You will serve as a culture and values ambassador and act as the line manager for designated local functions, as agreed with the Study Start‑Up and Site Partnership Director. You will be accountable for the successful delivery of all assigned operational trial activities across programs—whether managed directly by you or by your team—ensuring timelines, operational procedures, quality standards, SOPs, and guidelines are consistently met.

In this role, you will lead the day‑to‑day management of one or more dedicated functional groups within the local Country Operations Management team. You will oversee planning and resource utilisation, set objectives, drive performance development, and ensure your direct reports meet study expectations. You may also contribute to regional and global initiatives as delegated. In some countries, the AD COM may take on additional responsibilities—such as Project Manager, Country Operations (PMCO)—as needed.

• Leading and developing the dedicated functional group within Country Operations Management at local level.
• Ensuring adequate resources for the studies assigned, optimizing workload of direct reports, and ensuring appropriate and timely assignment to projects by liaising with relevant stakeholders (HCO, PMCO, global study team, etc).
• Development and performance management of direct reports, including implementation of development and training plan and regular coaching.
• Preparing salary and bonus proposals for direct reports based on their performance in close collaboration with responsible HCO.
• Managing new staff interviews, hiring, onboarding process for full‑time and outsourced staff.
• Ensuring that study activities at country level comply with local policies and code of ethics, and ensuring team delivery to committed activation and recruitment targets.
• Contributing to country feasibility analysis for new potential clinical trials (as applicable, depending on the direct reports the LM will be managing). Supporting the country external scientific engagement strategy and action plan.
• Contributing to efficient COM organisation and its functioning at country level by working closely with responsible HCO.
• Supporting HCO and in‑country COM activities as agreed with HCO, such as Site Oversight Visit reports review (as applicable) and onboarding and training of new in‑country COM functions and team members.
• Acting as extended local leadership team member with accountability to support the Country strategy implementation, champion the company values and support HCO with the local affiliate and global DRS team cross‑functional interactions required to support local COM goals.
• Contributing to the quality improvement of the study processes and other procedures through close partnership with DCQ at country level.
• Supporting inspection readiness activities at site and country level.
• Collaborating in identifying patient, site or country level quality deficiencies which may lead to the creation of quality events/issues, and supporting discussion around those as required (e.g.: CAPAs), including conducting Site Oversight Visits triggered by observed quality signals.

• Plan and conduct regular accompanied/assessment visits with CRAs.
• Provide support to their CRAs in managing site issues, from a monitoring perspective, ensuring that monitoring activities are conducted according to expectations.
• May act as a site liaison with prime sites for Alexion to facilitate discussion and consultation around site compliance to ICH GCP and process improvements, as agreed with their line manager.
• Collaborate with in‑country local roles (PMCO and DCQ) in monitoring quality oversight based on agreed KPIs. Maintain tools to document and track clinical monitoring activities as required.

• Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification.
• Minimum 8…