Position: Director, Study Start Up, BioPharma Site Management and Monitoring Location: Luton, UK Competitive salary and benefits Bring out the best in each other, and yourself, by working together as one In our dynamic environment, be supported by the brightest minds working together side by side. Agile and collaborative, we work cross-functionally, as well as externally, to thrive at pace. The Director, Study Start Up, Site Management & Monitoring (DSMM SSU) is accountable for collectively delivering the UK commitments for BioPharma clinical interventional studies 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 current vacancy will be responsible for SSU across all therapy area (TA) portfolio studies including specialty indications through establishing key relationships with partner organisations and KEEs. The DSMM SSU is accountable for ensuring that study sites are identified, site qualifications performed and set up through to site initiation /activation with close oversight and improvement of SSU KPIs expected. The DSMM SSU works closely with the TA DSMMs to strategically plan across TA portfolios ensuring optimal study placement and delivery. The DSMM SSU is responsible for line managing a dedicated team of staff responsible for SSU activities, including planning and utilization of SSU team resources, managing assigned resource budget, team objective setting and performance development. Experience in SSU within UK trials environment including collaboration with clinical trial networks is an advantage. Typical Accountabilities: Leadership of dedicated group, building the team spirit, developing team style and behaviour, promoting inclusion and diversity. Ensures adequate resources for the studies in feasibility/TA landscaping and SSU resource post country allocation. Ensures that the workload of direct reports is appropriate. Development and performance support of AZ direct reports, including coaching and mentoring. Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with Senior Director, BP Country Head and local HRBP. Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality. Contributes to the quality and process improvements of the study processes and other procedures. Ensures completeness and timeliness of the eTMF to maintain Inspection Readiness. Provides support and direction to Local Study Managers during SSU phase including identification and mitigation of risks. Supports SMM regional initiatives/activities as appropriate. Ensures collaboration with local Medical Affairs team in study identification and placement strategy across TAs. Ensures that study activities at country level comply with local policies and code of ethics. Supports Quality Manager in oversight of Country Quality Management Plans. Essential criteria : Bachelor degree in related discipline, preferably in life science, or equivalent qualification Relevant years of experience in Development Operations (CRA / SrCRA / Project Manager) or other related fields Line Management experience. Excellent interpersonal skills Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business Excellent organisational, analytical, influencing and negotiation skills Excellent presentation and communication skills, verbal and written Excellent knowledge of spoken and written English Good ability to learn and to adapt to work with IT systems Ability for national and international travel. Strong links with external organizations to support accurate feasibilities and efficient site and study set up in the UK (NIHR-CRN, NRS, HCRW etc) Ensure excellent understanding of the UK clinical trial environment, working externally to influence and improve the UK clinical trial environment (ABPI, HRA etc). Desirable criteria: Established knowledge of the Clinical Study Process and international ICH-GCP guidelines Knowledge of the risk-based Monitoring Process. Good understanding of the Study Drug Handling Process and the Data Management Process. Good knowledge of relevant local and international regulations. Good knowledge and ability to learn relevant AZ Therapeutic Areas. Ability to deliver quality according to the requested standards. Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. Ability to work in an environment of remote collaborators. Integrity and high ethical standards. Resource management skills. Decision-making skills. Financial management skills. Ability to manage conflict. Interviewing skills – responsibility for attracting, developing and retaining personnel. Excellent team building skills also in cross-functional teams. Good intercultural awareness. Ability to work according to global standards. Why AstraZeneca At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development Ready to make a difference? Apply now Opening Date for Applications: 15 January 2025 Closing Date for Applications: 31 January 2025 Date Posted 15-Jan-2025 Closing Date 31-Jan-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.