Associate Director Biosampling Project Leader
Human Biological Samples (HBS) are fundamental to medical research in the discovery, development, and implementation of new treatments and diagnostics. They are ethically sensitive materials and underpin the delivery of every clinical trial at AstraZeneca. The Biosampling Project Leader (BPL) is accountable for in-scope clinical sampling aspects of all studies in their program delivered in a therapy area (TA). These programs will be allocated by the Clinical Sampling Leadership team. The role holder achieves these goals as a member of a team of clinical sampling experts who provide HBS expertise to meet the needs of the R&D clinical portfolio. The Biosampling Project Leader delivers their goals via the use of defined, compliant policies and operating models.
Accountabilities
• Works independently on the allocated clinical programs to manage in-scope HBS activities within a clinical program.
• Accountable for compliance of the clinical sampling lifecycle via planning, risk management, and GCP sponsor oversight and monitors progress to track study delivery to resources, time, and quality.
• Accountable for operational optimization through planning, accuracy of operational study documents, and communicating lessons learned within and across programs.
• Maintains oversight of clinical sampling delivery within the assigned clinical programs, including risk logs and escalates issues for resolution in a timely, accurate, and compliant manner.
• Accountable for oversight of central laboratory and biobanking HBS activities within clinical programs to agreed time and quality and for reporting of these metrics to senior project leadership as necessary.
• Works independently and prioritizes work for self and colleagues to meet business objectives.
• Monitors and ensures compliance with all AstraZeneca Policies and Standards and immediately addresses instances of non-compliance. Delivers ethical and compliant management of Budget, Safety, Health, and Environment within their assigned activities and on behalf of the PMB Function as required.
• Provides and problem solves operational aspects of the inclusion of central laboratory testing of HBS into clinical programs and trials using best practice project management skills.
• Oversees delivery of laboratory services and data from key external partners at a clinical program level. Problem solves delivery from key external lab partners to ensure timely delivery of relevant lab services and data.
• Supports Biosampling Business Area Leaders as required, including contribution to recruitment, retention, and onboarding of new employees.
• Contributes to the development of current new processes, including adoption of new automation or digital technologies as a Subject Matter Expert.
• Contributes to the validation and assessment of technologies that can transform end-to-end HBS processes.
• Develops, maintains, and applies ongoing knowledge and awareness in trends, best practices, and innovation in HBS technologies.
Essential Skills/Experience
• Degree (or relevant equivalent qualification) in relevant area, or equivalent industry experience.
• Proven experience in contributing to operational deployment of clinical laboratory testing including HBS compliance.
• Proven experience in oversight of external partners, especially clinical laboratory service providers.
• Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice, and Quality Systems Regulation.
• Strong organization and forward-planning skills, with attention to detail.
• Experience of global matrix team-working and communicating with key stakeholders.
• A professional, enthusiastic, and proactive approach, with the ability to independently manage a diverse and demanding workload.
• A confident team player who is assertive but willing to listen and learn from the views of others.
Desirable Skills/Experience
• Scientific experience relevant to the role
• Previous experience in a similar role
• Understanding of Project Management techniques, tools, and principles
• Experience of using Microsoft Office/ Outlook and web-based programs
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we follow the science with curiosity and determination. Our commitment to Oncology R&D is driven by our ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we fuse cutting-edge science with the latest technology to achieve breakthroughs. Our collaborative research environment unites some of the world's foremost medical centers, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career dedicated to improving millions of lives.
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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 authorisation and employment eligibility verification requirements.
