Biorepository Associate II / III

Organization
AstraZeneca Pharmaceuticals
Job Location
Mountain View, CA
Job Description

If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As a Biorepository Associate II / III in Mountain View, CA, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
And we're excited to share that our work at the Mountain View site (along with some other AstraZeneca Group Companies in the Bay Area) will relocate to South San Francisco by end of 2017.  Click here for more information on this new facility. 
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.



Requirements: 

Main Duties and Responsibilities 
As theTranslational Sciences Biorepository Associate II/III, you will be responsible for coordination of planning, data management and specimen lifecycle activities associated with pre-clinical and clinical trial specimens for testing within MedImmune Translational Sciences laboratories.  The position is complex and requires sound understanding of relational database and data management concepts.
Responsibilities include:

•Operating in FDA regulated environment, manage Translational Sciences Biorepository (TSB) study lifecycle activities for assigned studies across Therapeutic Areas. 
•Create, review and maintain study related documents including specimen plans and data specifications. 
•Work closely with study team personnel including: Clinical Operations, Clinical Data Management, Translational Science, and External Laboratory vendors.  Represent Translational Science Biorepository at study related team meetings
•Execute routine and non-routine data entry/upload into LIMS database, review and perform edit checks. Provide test, header and production data to internal/external stakeholders.  Generates study reports/metrics for data cleaning and complex reconciliations between multiple data sources
•Coordinate specimen and data delivery timelines for TSB
•Manage specimen requests, evaluate available inventory and assign usage
•Monitor Central Lab compliance with Translational Science Biorepository standards and escalate issues as necessary
•Actively participate in TSB continuous process and quality improvements.  As Subject Matter Expert, train new staff and guide peers in areas of specific expertise.
•With sound understanding of CS&DM internal practices and policies, independently problem solve and strategize to resolve issues to ensure study timelines and objectives are met
•May include responsibilities for management of TSB laboratory equipment life cycle. 
Essential Requirements 
For both Biorepository Associate II & III: 

• Bachelor's degree in health, scientific or data related discipline.  May be replaced by equivalent industry experience 
• Advanced MS Excel skills including pivot tables, Vlookup and other logic functions 
•Excellent written and verbal communication skills with strong ability to communicate clearly and concisely 
For Biorepository Associate II: 

• Minimum of 1-2 years experience in a related setting required 
•Provides solutions to a variety of problems of difficult scope and complexity with management input
•Ability to work collaboratively with sound judgment in cross functional teams 

For Biorepository Associate III: 

• Minimum of 4 years experience in a related setting required 
• Independently provides solutions to a variety of problems of difficult scope and complexity 
• Ability to work independently and collaboratively with sound judgment in cross functional teams 
•Operates autonomously with infrequent managerial input 
Desirable Requirements 
•LIMS or EDC system experience
•Experience with relational databases, knowledge of the Clinical Trials and/or pre-Clinical study process and FDA GxP
•Ability to multi-task effectively and prioritize workload with a sense of urgency in moving project forward
•Establishes positive, collaborative relationships with MedImmune peers, senior management and external vendors 

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