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 Clinical Data Coordinator 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.
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. Main Duties and Responsibilities
Operating in FDA regulated environment, you will perform Translational Sciences Biorepository (TSB) data management 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.
Execute routine and non-routine data entry/upload into LIMS database and generate ad-hoc reports to facilitate in data review and reconciliation.
Perform data review and edit checks. Issue queries to sites, central laboratories, monitoring CROs, and/or Clinical Operations, and apply updates to database as identified through query resolution, data review, etc.
Provide test, header and production data to internal/external stakeholders according to data specifications. Ensure data delivery timelines for TSB are met.
Monitor Central Lab compliance with TSB standards/ specifications, and escalate issues as necessary.
Actively participate in TSB continuous process and quality improvements.
As Subject Matter Expert, you will train new staff and guide peers in areas of specific expertise. With sound understanding of TSB internal practices and policies, independently problem solve and strategize to resolve issues to ensure study timelines and objectives are met.
Position and management of systems is complex and errors in judgment would have a serious impact on the organization. Independently provide solutions to a variety of problems of difficult scope and complexity. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules.
- Bachelor's degree in health, scientific or data related discipline. May be replaced by equivalent industry experience.
- Four or more years of experience in a related setting.
- LIMS or EDC system experience.
- Experience with relational databases, knowledge of the Clinical Trials and/or pre-Clinical study process and FDA GxP.
- 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
- 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
- Ability to work independently and collaboratively in cross-functional teams
- Ability to operate autonomously with infrequent managerial input
NOTE: This position is scheduled to move to South San Francisco in late Q4 2017 / Q1 2018 timeframe.
Next Steps -- Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law