Biosampling Project Lead, Precision Medicine and - Barcelona, España - AstraZeneca

AstraZeneca
AstraZeneca
Empresa verificada
Barcelona, España

hace 3 semanas

Isabel García

Publicado por:

Isabel García

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Descripción

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 guides 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 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 lead 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 learned within and across programs.
  • Maintains oversight of clinical sampling delivery within the assigned clinical programmes, including risk logs and brings up 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 noncompliance. 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.
  • Leads all aspects of delivery of laboratory services and data from key external partners at a 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 onboarding of new employees.
  • Give 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.
  • Shown experience in contributing to operational deployment of clinical laboratory testing including HBS compliance.
  • Shown 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 forwardplanning skills, with attention to detail.
  • Experience of global matrix teamworking and communicating with key partners.
  • A professional, hardworking and proactive approach, with the ability to independently handle a diverse and demanding workload.
  • A confident teammate 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 webbased programmes
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