Biosampling Project Leader

5 months ago

Mississauga, Canada AstraZeneca Full time

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

**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 and are critical to to AZs Bold Ambition to launch 20 new drugs by 2030.

Biosamples provides expertise on Human Biological Samples for all of AZ. We lead the sampling, analysis and logistics on every clinical program, the registration and storage of samples in the biobanks to support future science and the HBS compliance and governance to make sure that every human sample is treated in the right way. Together, through our operational and scientific expertise, we ensure quality samples, whether collected or purchased, are managed effectively and compliantly across their life cycle. Securing access to the right patients, the right assays and the right data and ensuring clinical trial compliance with GCP and HBS regulations.

**What You’ll Do**

The Biosampling Project leader (BPL) is a clinical operations orientated leader accountable for the oversight of all HBS or Biospecimens in their projects or programs. BPLs are expected to handle a broad portfolio of projects and could work in any of the AZ Therapy Areas - Oncology, Cardiovascular, Renal, Metabolism, Respiratory, Inflammation, Vaccine, Immune Therapies and Rare Diseases. The BPL is accountable for strategic planning and oversight of all central HBS related activities 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 and clinical bioanalysis for pharmacokinetic assessment). BPLs work across the entire AZ clinical portfolio covering all clinical trial phases and sampling related activities in R&D and Affiliate projects.

In the role as BPL you are expected to be able to work independently and be comfortable to prioritize the work for yourself to meet business objectives. BPLs are also part of improvement initiatives and you may contribute to functional and cross-functional initiatives as a Subject Matter Expert. You will work closely with our external lab partner to ensure timely delivery of relevant lab services and data and provide mentoring and support to colleagues at all levels of experience.

**Accountabilities**
- Accountable for sponsor oversight of the central laboratory activities within the clinical studies in the assigned programs using best practice project management and communication skills
- Accountable for overseeing the compliance of the clinical study sample lifecycle where responsibility is delegated to the Biosampling Project Manager, Clinical Sample Scientist, study team and science functions
- Provide appropriate operational contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials
- Ensure all the laboratory components within planning operational delivery documents are accurate and fit for purpose.
- Ensuring strategy for the project sampling plan is deployed and lessons learnt within and across programs are communicated to the study level personnel
- Oversee delivery of laboratory services and data from external providers at a project and occasionally study level to understand and mitigate risks to delivery
- Act as the first point of escalation for HBS, sample and lab issues to bring expertise to resolve problems
- Provide business oversight of external laboratory budgets
- Maintains an up to date knowledge of current sample management and analysis techniques and regulations
- Contribute to clinical laboratory training & education and to maintenance of relevant SOPs, guidelines, and tem

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