Manager, Diagnostics (Biomarker Data Lead) - 12 Month Fixed Term Contract/Secondment

Manager, Diagnostics (Biomarker Data Lead)

Warsaw, Poland (1 position)

12 Month Fixed Term Contract or Secondment

Precision Medicine and Biosamples (PMB) within AstraZeneca focuses on matching medicines to those patients who will benefit from them most and delivers companion or complementary diagnostic assays that align with the drug development process and enable personalised healthcare approaches within our clinical portfolio. 

This role sits within the Diagnostic and HBS Science (DSS) department which delivers the scientific and regulatory aspects of diagnostic test establishment in our external testing laboratories, quality control for the delivery to clinical studies, and delivery of data packages to enable regulatory approvals including studies to support market adoption and life cycle management. Diagnostic and HBS Science also drives the development of innovative diagnostic science across core therapeutic areas and disciplines.

As a part of a cross-functional team of data and technology experts you will help to shape future biomarker data vision for PMB DSS through implementation of new compliant data governance framework, standardized & streamline data flows as well as fit-for-purpose automation aligned with wider AZ data strategy.

Key responsibilities:

• Act as Subject Matter Expert (SME) for biomarker data operations, data governance and superuser of automation tools.
• In collaboration with DSS Data Stewards, use understanding of current process & compliance gaps to improve data flows and bring innovative approaches to increase efficiency of biomarker data management.
• Assure quality and integrity of data; through developing and implementing new data standards.
• Work with internal & external stakeholders to ensure that data management activities are conducted in compliance with appropriate regulatory standards and company procedures.
• Identify opportunities and drive communication, procedural document generation, training, and education to re-shape DSS data culture.
• Support Alliance Management team in interactions with external Third-Party Vendors to improve transfer of data between organisations.

Oversee management and storage of diagnostic data within AZ systems and tools in compliance with data best practices and processes (FAIR principles = Findable, Accessible, Interoperable & Reusable)

• Work together with Data Governance Lead, Data Implementation Lead, and other data subject matter experts (engineers, domain leads, data curators, scientists) to implement new templates, standards and vocabularies in support of proactively streamlining the flow of diagnostic data (harmonised processes in place)
• Coordinate data transfer, exchange and integration activities with external collaboration partners including Diagnostic Partners, Testing laboratories and Contract Research Organisations etc.
• Help shape our data centricity vision, bringing new innovative ideas and novel approach to rethink the way we manage, treat, handle, and govern data.

This role is also required to:

• Operate across internal and external partners in a global multi-disciplinary environment, applying scientific, technical, and operational expertise. Identify opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable Diagnostic Development outcomes.
• Building and maintaining a knowledge of current and emerging diagnostic technologies / biomarkers in area of expertise.
• Drive continuous improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, adding value to projects, and delivering better medicines to patients.
• Be accountable for the time, cost, and quality of agreed deliverables.
• Provide updates on the progress, risks, and opportunities of the agreed deliverables to the appropriate governance bodies for review, challenge, and issue resolution.
• Take on small supervisory or skills transfer / training roles.
• Monitor and ensure compliance with all AstraZeneca Policies and Standards, and local law/regulation, and immediately address instances of non-compliance. 

Essential Minimum:

• BSc or equivalent experience in relevant subject.
• Strong attention to detail and analytical skills.
• Knowledge of data management best practices and principles and competence using data repositories (e.g., Sharepoint)
• Strong understanding of data systems, data management & related tools.
• Experience of working in collaborative or multi-functional initiatives.
• Excellent verbal and written communication skills.

Desirable:

• Operational experience of clinical trial set up, documentation and QC / monitoring of molecular and tissue testing.
• Advanced degree or equivalent experience in a relevant area.
• An understanding of clinical and diagnostic development.
• Knowledge of applicable laboratory testing regulations such as ICH/GCP, CAP/CLIA and Quality Systems Regulations.
• Experience with Third Party Vendor data management.
• Familiarity with data visualization tools (e.g., Power BI).

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.