Research Assistant managing data and databases for clinical trials at Monash Health. Collaborating with clinical trial coordinators and maintaining professionalism for patient interaction.
About the role
- Principal Scientist in translational medicine at AstraZeneca, focusing on diagnostic development and strategic planning. Collaborating globally on regulatory submissions and innovative diagnostic technologies.
Responsibilities
- Delivery of diagnostic testing to clinical studies as agreed with project leaders
- Lead the delivery of diagnostic data work packages to enable regulatory submission and approval
- Build and maintain a knowledge of current and emerging diagnostic assay technologies to fulfill precision medicine approaches
- Make milestone-driven plans including measurable outcome success, criteria, risk/mitigation plans
- Regularly update scenarios and contingencies based on evolving data and operational realities
- Prioritize hypotheses and studies for maximum impact and resource efficiency
- Integrate input from clinical, data sciences, regulatory, CROs, central labs etc. to drive consensus and accountable delivery
- Select, onboard, and manage CROs, central labs, bioanalytical partners, and data vendors
Requirements
- PhD, MD, or PharmD in a relevant field (e.g., human genetics, molecular/cellular biology, immunology, neuroscience, metabolic disease) with 4–6+ years of industry experience; or MS with 8–10+ years.
- Fluent English communication and presentation.
- Demonstrable experience of analytical diagnostic assay validation and the use in a clinical testing setting.
- Knowledge of clinical trial sample biomarker testing procedures, and applicable laboratory testing regulations and quality systems (eg, GCP, CAP, CLIA, etc)
- Proven experience of delivery and use of data for diagnostic projects - including quality control, test data monitoring and troubleshooting.
- Experience of working with diagnostic partners to drive timely and successful outcomes, through effectively working across internal and external boundaries.
- Experience of working within a global team.
- Knowledge in Tissue diagnostic technologies (IHC, FISH, Dual-ISH, etc)
Benefits
- AstraZeneca is an equal opportunity employer
- We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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