Director, Site Management and Monitoring (Oncology R&D)
Location: Cambridgeshire, Luton
Job Type: Full time
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 world’s most serious diseases. But we’re more than one of the world’s 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.
Locations: Luton UK and Cambridge UK
Come and join our AZ team where you will play a pivotal role in this exciting period of development!!
The Site Management and Monitoring (SMM) organisation, with staff across the globe, is responsible for global site management delivery across the Oncology portfolio. The Director, Site Management and Monitoring (DSMM) is accountable for delivering the committed part of oncology and haematology clinical interventional studies under their supervision according to agreed resources, budget and timelines aligning with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
Leadership of dedicated group, building the team spirit, developing team style and behaviour.
Ensure adequate resources for the studies assigned and that workload is adequate
Develop and manage performance 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/organizes coaching with external providers if needed.
Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible CH/CD SMM and local HRBP.
Contributes to efficient SMM organization and its functioning at country level by working closely with responsible CH/CD SMM.
Contributes to high quality feasibility work if applicable.
Oversees 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 CH/CD SMM or LSAD/teams in forecasting study timelines, resources, recruitment, study materials and drugs.
Provides direction to LSAD/teams on major study commitments including resolving any key issues identified.
Supports SMM region/global in initiatives/activities as agreed with CH/CD SMM.
Ensures collaboration with local Medical Affairs team and global partners.
Ensures that study activities at country level align with local policies and code of ethics.
Reviews SQV reports of direct reports in line with AZ SOPs
Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans
Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development
Bachelor’s of Science in an appropriate field
Extensive experience in Study Management within a pharmaceutical or clinical background
Thorough knowledge of Study Management processes and local regulations
Excellent communication and relationship building skills
Advanced degree in a scientific field
Experienced reputation within the business and industry
Extensive knowledge of the latest technical and regulatory expectations
*** We will be reviewing applications and shortlisting on a rolling basis - as such we reserve the right to withdraw this vacancy ahead of the stated closing date
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, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
So, what’s next:
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you!
Closing date: 18th December 2022
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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.