Diagnostic Clinical Operations Manager, Diagnostic
hace 3 semanas
Precision Medicine and BioSamples 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.
As a member of the **Biopharm Diagnostics team** you will drive diagnostic development across a wide range of chronic disease areas and diagnostic technologies
Your objective will be to ensure that complementary & companion diagnostic tests, or equivalent patient segmentation tools, are delivered to drug projects. Specifically, you’d be:
- Providing logístical/deployment assessment of Diagnostic assay options
- Delivering diagnostic testing to clinical studies as agreed with project leaders including: diagnostic test establishment in partner laboratories, monitor diagnostic test data for quality control, provide scientific troubleshooting when necessary, preparation of study reports with presentation at appropriate meetings and ensure inspection readiness
- Accountable for the operational, scientific and regulatory aspects of establishing and controlling diagnostic tests used to identify patients who are eligible to enter drug clinical trials.
- Developing and maintaining QC and monitoring toolbox and processes across Biopharma portfolio
- Finding opportunities, propose solutions and work across boundaries in the scientific area(s) of expertise that will enable drug development projects and diagnostics labelling.
- Generating scientific evidence to enable companion diagnostic test selection, regulatory submissions and diagnostic test life-cycle management.
- Building and maintaining a knowledge of current and emerging diagnostic technologies in area of expertise.
- Driving improvement in the scientific area(s) of expertise, aligned to Precision Medicine strategic objectives of increasing project success, making valuable contributions to projects and delivering better medicines to patients.
- Being accountable for the time and quality of agreed work.
- Providing updates on the progress, risks and opportunities of the agreed work to the appropriate governance bodies for review, challenge and issue resolution.
- Taking on small supervisory or skills transfer / training roles
**Essential Minimum**
- Experience of working in collaborative or multi-functional initiatives
- Excellent verbal and written communication skills
- Knowledge of immunoassays, such as ELISA, or mass spectrometry including troubleshooting and QC
- Operational experience of clinical trial set up, documentation and QC / monitoring of tissue testing
**Desirable**
- Advance degree or equivalent experience in a relevant area
- An understanding of clinical and diagnostic development and commercialisation.
- Knowledge of clinical testing procedures and applicable laboratory testing regulations such as Good Clinical Practice, CAP/CLIA, Good Clinical Practice and Quality Systems Regulation.
**Locations**
- Cambridge, UK (primary)
- Barcelona, Spain
- Warsaw, Poland
**Salary**:Competitive + Excellent Benefits
**Where can I find out more?
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