Biosampling Project Lead, Precision Medicine and Biosamples

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 in 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 use of defined, compliant policies and operating models.

The BPL is accountable for strategic planning and oversight of all central laboratory and biobanking HBS related activities in a program from initial study design through to long term storage post study closure. The BPL drives consistency, quality and compliance across their programs and they are the catalyst for efficient operational deployment of clinical sampling and laboratory testing (including biomarkers, central safety testing, diagnostics, PK, ADA and HBS for research).

Typical Accountabilities
Works independently on the allocated clinical programmes to manage in scope HBS activities within a clinical programme.
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 optimisation through planning, accuracy of operational study documents and communicating lessons learnt within and across programs.
Maintains oversight of clinical sampling delivery within the assigned clinical programmes, 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 programmes 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 ensure compliance with all AstraZeneca Policies and Standards and immediately address 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 programmes and trials using best practice project management skills.
Oversees delivery of laboratory services and data from key external partners at a clinical programme 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 on-boarding of new employees.
Contribute to the development of current new processes, including adoption of new automation or digital technologies as a Subject Matter Expert.
Contribute 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 practice and innovation in HBS technologies
Education, Qualifications, Skills and Experience

Essential
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 organisation 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
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 programmes
Date Posted 13-oct-2023

Closing Date 12-nov-2023

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.
AstraZeneca

Fecha de publicación: 15/10/2023