Clinical Information Science Principal, Cvmd
AstraZeneca / Läkarjobb / Göteborg
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At AstraZeneca every one of our employees makes a difference to patient lives every day. Each one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.
At AstraZeneca our Biometrics & Information Sciences (B&I) department is an integral part of Global Medicines Development (GMD) and is the home of statistical, programming and information experts for late stage drug development.
As the Clinical Information Science Principal (CISP) within Cardiovascular and Metabolic Disease (CVMD) you will be accountable for maximising the value of information in the development of late-stage drug projects. The CISP delivers the Information Practice services for a project, overseeing driving the re-use of our clinical data and information assets, and providing processes to capture and retain drug project knowledge.
Main Duties
You will work in in the Information Practice (IP) group with other Information experts who lead the re-use of our clinical data and information assets in our drug development programs. Reporting to the Therapy Area Information Science Director you will act as a member of a therapy area team deployed to Drug Project(s) to support specific pieces of work.
Information Science Leadership
* Develop and execute the Project Information Strategy, which identifies information and IP services needed to support drug project goals and milestones.
* Identify external opportunities such as industry collaborations and information sources.
* Contribute to the TA Information Strategy.
* Lead and deliver the due diligence for Information Sharing requests, document requests, and capture the knowledge and value generated.
* Lead Information Transfer in partnerships, in-licensing deals and other strategic relationships so that both parties can access required information.
* Lead and deliver drug Project Memory (key decisions, rationale, and supporting documents) and ensure that the asset is maintained over time.
* Lead the team handling requests for additional analysis/output (IEMT). Organise and record how the drug project clinical data has been re-used for primary and secondary analyses.
* By demand, lead Design Teams, quantification of Benefit-Risk assessments (BRAT) and probability of technical success (PTS).
Information Management & Delivery
* Use internal and external information sources/information science techniques to provide
* decision makers with relevant and needed information to support project decisions
* Provide clinical information to support project decisions (e.g., TPP, BRAT, Go/NoGo, design
* assumptions and options, PTS, contextualized interpretation) and information to
* support submissions and Regulatory and Payer responses. Use effective communication
* techniques to bring facts, evidence and data to the team.
* Provide Clinical Intelligence to support project needs, by defining key intelligence topics and
* questions, and utilizing appropriate sources and tools.
* Ensure adherence to AstraZeneca information sharing policies.
* Advocate Good Information Practice principles.
Drive innovation and continuous improvement through delivery in TA, B&I and IP initiatives
* Contribute to an environment in which innovation can flourish
* Lead and contribute to improvements in productivity, quality, competitive positioning and customer focus and growth.
Minimum requirements:
* Bachelors degree in a Life Science, Computer Science or Information Science.
* Recognised as an information science/information management expert with proven ability to influence strategic decision making within a multidiscipline and multicultural setting.
* Clinical drug development experience and knowledge.
* Extensive experience in the application of information and knowledge management within pharmaceutical, biotech or technology industries.
* Excellent communication skills and facilitation skills.
* Project management skills and ability to apply these in a multidiscipline and multicultural setting.
Preferred experience:
* Experience from supporting clinical submissions process.
* Strong experience in a range of clinical design projects within the drug development setting.
* Knowledge and exposure to the one or more of Therapeutic Areas in which AZ specialises (Oncology, Respiratory, Inflammation, Cardiovascular and Metabolic Disease).
Apply today!
For more information about the position please contact Thomas Rask at +46 31 776 22 10
Closing date for applications - 6th March2018
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.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-02-15ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-03-04
Ange följande referens när du ansöker: R-020728
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
daniela.borquez@astrazeneca.comFöretagAstrazeneca
AdressAstrazeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 3967771
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