Biosampling Project Manager

4 days 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 fito 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 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 handled 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 Manager (BPM) is clinical operations focused, specifically accountable for the oversight of all HBS or Biospecimens in their studies. BPMs are expected to handle the most complex and novel studies in AZs portfolio and could work in any of the AZ Therapy Areas - Oncology, Cardiovascular, Renal, Metabolism, Respiratory, Inflammation, Vaccine, Immune Therapies and Rare Diseases. The BPM is accountable for management and oversight of all central HBS related activities from initial study design through to long term storage post study closure. The BPM leads efficient operational deployment of clinical sampling and laboratory testing (including biomarkers, central safety testing, diagnostics and clinical bioanalysis for pharmacokinetic assessment). BPMs 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 BPM you are expected to be able to work independently and be comfortable to prioritize the work for yourself to meet business objectives. BPMs 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 external lab partners to ensure timely delivery of relevant lab services and data.

**Accountabilities**:

- Provide appropriate operational contribution to the inclusion of laboratory testing of human biological specimens into clinical programmes and trials using best practice project management skills
- Ensure all the laboratory components within planning operational delivery documents are accurate, compliant and fit for purpose
- Oversee delivery of laboratory services and data from external providers at a study level
- Provide business oversight of external laboratory budgets at a study level
- Ensure compliance of the assigned sampling activities
- Provide business oversight of external laboratory activities and milestones at a study level
- Support clinical study teams in the delivery of laboratory requirements
- Support sampling project leaders on complex programs where extra oversight is required
- Can be assigned to specific tasks across Biosamples as required
- Contribute to the development of new processes and deployment of automation technologies.
- Contribute to the validation and assessment of technologies that can transform end to end Biosamples processes

**Essentials**:

- Degree (or relevant equivalent qualification) in relevant area, or equivalent industry experience.
- Fluent in English as the AstraZeneca working language
- A clear demonstration of behaviours of
- Truth seeking rather than success seeking
- Agile responsiveness to scientific data
- Embracing of peer review
- Problem solver
- Project management

**Desirables**:

- Clinical Laboratory scientific experience
- Experience in more than one

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