Director, Site Management & Monitoring

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention. The Director Site Management & Monitoring (DSMM) is accountable for delivering the committed part of all clinical interventional studies under their supervision according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The DSMM is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up. It is also expected that the DSMM may contribute to regional/global work tasks as delegated. As assigned, the DSMM is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, supervised, closed and documentation archived. In some countries a DSMM may also take ownerships as Local Study Associate Director (LSAD) or Clinical Quality Associate Director (CQAD) if required and agreed with the (Senior) Director, Country Head. Typical Accountabilities: • Leadership of dedicated group, building the team spirit, developing team style and behaviour. • Ensures adequate resources for the studies assigned. • Ensures that the workload of direct reports is adequate. • Development and performance management of direct reports. • Ensures that direct reports have development and training plans, according to IDP process. • Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed. • Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP. • Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head. • Contributes to high quality feasibility work. • Supervises successful delivery of SMM study delivery country level targets to plan, with speed and quality. • Contributes to the quality improvement of the study processes and other procedures. • Ensures all systems are continuously updated. • Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”. • Assists (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs. • Provides direction to LSAD/ Local Study Teams on major study commitments including resolving any key issues identified. • Supports SMM region in initiatives/activities as agreed with (Senior) Director, Country Head. • Ensures collaboration with local Medical Affairs team. • Ensures that study activities at country level align with loc