Director, Site Management & Monitoring

Overview

The Director, Site Management & Monitoring (DSMM) is accountable for the effective leadership and performance of the assigned team, ensuring the successful delivery of all clinical interventional studies under the oversight of the Country Head, and in line with agreed resources, budgets, and timelines. The role has overall responsibility for a dedicated team, including line management, resource planning and utilization, budget management, objective setting, and performance oversight. The DSMM also contributes to regional and global initiatives as delegated and provides support to the Country Head when required. In this capacity, the DSMM ensures the team identifies appropriate study sites, conducts site qualification activities, and oversees that sites are properly set up, initiated, monitored, and closed, with all study documentation accurately archived.

Key Responsibilities

• Lead and develop a high‑performing team by fostering a positive culture, ensuring appropriate staffing and workload distribution, and maintaining professional behaviours across the group.
• Ensure each direct report has a current Individual Development Plan (IDP), provide ongoing coaching and mentorship, and arrange external development opportunities where appropriate.
• Prepare salary and bonus recommendations based on performance, in collaboration with the (Senior) Director, Country Head and local HR Business Partner.
• Conduct and review accompanied site visits, co‑monitoring visits, and Quality Control (QC) visits in line with local QC plans, using these as opportunities for coaching and continuous development.
• Oversee the achievement of Site Management & Monitoring (SMM) delivery targets at country level, ensuring timely, high‑quality completion of all study milestones and that operations conform to local policies, the company's code of ethics, and regulatory requirements.
• Contribute to feasibility assessments and support forecasting of timelines, resources, recruitment, study materials, and drug supply for clinical studies.
• Provide strategic guidance to local study associate directors and study teams on major deliverables, proactively identifying and resolving priority issues to maintain portfolio momentum.
• Partner with the (Senior) Director, Country Head to ensure efficient SMM operations, support regional SMM initiatives, and represent the organisation in local regulatory or operational external expert groups as needed.
• Ensure all required systems are maintained and that the electronic Trial Master File (eTMF) remains complete, current, and inspection‑ready.

Qualifications

• Bachelor's degree in a related subject area, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role.
• Experience in the pharmaceutical industry and in clinical operations, with significant exposure to Site Management & Monitoring (SMM) activities.
• Direct line management experience with proven ability to provide direction, oversight, and coaching to LSADs and broader study teams, including resolving operational issues, supporting development, and driving delivery against agreed priorities.
• Relevant knowledge in drug development process and related GxP processes, International guidelines ICH‑GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including monitoring, study drug handling and data management.
• Demonstrated experience contributing to feasibility assessments and leading the successful delivery of clinical interventional studies at country level, with accountability for quality, timelines, and operational performance.
• Solid understanding of GCP, quality management, and inspection readiness requirements, with hands‑on experience ensuring eTMF completeness, timeliness, and inspection‑ready standards.
• Demonstrated capability in forecasting and managing study timelines, resources, recruitment, study materials, and drug supply, with the ability to anticipate risks and implement mitigations.
• Demonstrated ability to lead and motivate cross‑functional teams to deliver according to or ahead of time plan, budget and with required quality.
• Proficiency with clinical trial management systems (CTMS), eTMF platforms, and the ability to leverage metrics for performance improvement and decision‑making.
• Experience conducting or overseeing quality oversight visits and ensuring adherence to local quality management plans.
• Experience leading delivery through collaboration with internal and external providers.
• Proven project management experience.
• Ability to travel nationally/internationally as required.

Benefits

Competitive salary and benefits package on offer. The successful candidate will have access to a flexible employee benefits fund, including holiday purchase and flexible time off, pension contributions, Share Save Plans, a performance recognition scheme, and a competitive, generous remuneration package.