Director, Site Management & Monitoring[

Director Site Management & Monitoring

Luton UK (on site 60% per month).

About AstraZeneca

AstraZeneca is a global science-led patient-focused biopharmaceutical company that focuses on the discovery development and commercialisation of prescription medicines for some of the worlds most serious diseases. But were more than one of the worlds leading pharmaceutical companies. At AstraZeneca we are pioneering new frontiers by identifying and treating patients earlier working towards the aim of eliminating cancer as a cause of death.

Come and join our AZ team where you will play a pivotal role in this exciting period of development!

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 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:

• Team leadership & culture: 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.

• Talent development & coaching: Ensure each direct report has a current Individual Development Plan (IDP) provide ongoing coaching and mentorship and arrange external development opportunities where appropriate.

• Performance & reward: Prepare salary and bonus recommendations based on performance in collaboration with the (Senior) Director Country Head and local HR Business Partner.

• Quality assurance & field oversight: 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.

• Study delivery & operational excellence: 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 companys code of ethics and regulatory requirements.

• Strategic planning & resourcing: Contribute to feasibility assessments and support forecasting of timelines resources recruitment study materials and drug supply for clinical studies.

• Direction & issue resolution: Provide strategic guidance to local study associate directors and study teams on major deliverables proactively identifying and resolving priority issues to maintain portfolio momentum.

• Collaboration & external engagement: 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.

• Systems & inspection readiness: Ensure all required systems are maintained and that the electronic Trial Master File (eTMF) remains complete current and inspection-ready.

Requirements:

• Bachelors degree in 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 toLSADsand broader study teams including resolving operational issues supporting development and driving delivery against agreed priorities.

• Relevant knowledge in drug development process and knowledge 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 tofeasibility assessmentsand leading the successful delivery ofclinical interventional studiesat country level with accountability for quality timelines and operational performance.

• Solid understanding ofGCP quality management and inspection readiness requirements with hands-on experience ensuringeTMF completeness timeliness and inspection-ready standards.

• Demonstrated capability in forecasting and managingstudy 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

In Office Requirement:

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

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.

Date Posted

Closing Date