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 II or 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.
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. Main Duties and Responsibilities
As Clinical Data Coordinator II or III, you will be operating in FDA regulated environment and will perform Translational Sciences Biorepository (TSB) data management activities for assigned studies across Therapeutic Areas. You will create, review and maintain study related documents including specimen plans and data specifications. Additionally, you will work closely with study team personnel including: Clinical Operations, Clinical Data Management, Translational Science, and External Laboratory vendors. You will execute routine and non-routine data entry/upload into LIMS database and generate ad-hoc reports to facilitate in data review and reconciliation.
Additional Responsibilities include:
- 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.
- With understanding of TSB internal practices and policies, work with peers to 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. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules.
For Clinical Data Coordinator III:
You will be expected to manage studies that are more complex, high priority, and more active. You will also be expected to independently troubleshoot issues encountered and contribute more towards process improvements. Regarded as subject matter expert on a particular process, you may provide guidance to more junior level peers.
For Clinical Data Coordinator II Bachelor’s (or equivalent industry experience) with 2 years or more experience in related field
For Clinical Data Coordinator III
Bachelor’s (or equivalent industry experience) with 4 years or more experience in related field 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.
- Intermediate 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
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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.