Clinical Research Data Management Quality Leader
AstraZeneca / Datajobb / Göteborg
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hela Sverige AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity
We are looking for a Data Management Quality Leader (DMQL), located within Clinical Research Data Management, Clinical Operations in Global Medicines Development in Gothenburg,
As a Data Management Quality Leader (DMQL) you will ensure that all clinical data management tasks in your studies will be delivered to time, quality and cost.
As a member of the study team(s), you will provide Clinical Research Data Management (DM) leadership and subject matter expertise to the study team(s) and you will be responsible for overseeing and managing all DM activities for the study, including.communications, specifications, and documentation. You will be responsible for the overall quality and integrity of the clinical database with respect to critical to quality data points predefined by Clinical and Biostatistics prior to the start of a study.
Major Duties and Responsibilities:
* Expertise in Clinical Research Data Management (DM) to provide oversight and advice to the clinical study team(s) regarding the DM activities and deliverables
* Development and oversight of DM processes and standards and functional leadership:
* Management and oversight of vendor contracts, resourcing and budgets
* Accountability for the execution and overall quality of DM activities and deliverables.
* Responsibility for acting as the single point of contact for all data management deliverables for the study team during the study set-up phase, responsible for the CRF design, DB specifications (including edit checks, CRF working instructions, etc.), during study conduct, and study close-out activities.
* Guidance and supervision to Lead Data Managers working on the study (Cognizant, Contract Research Organisation or in-house)
* Responsibility for working closely with the Centralized Monitoring group to ensure quality and integrity of our most important data points.
Minimum experience
Only requirements should be described here, this is only what is considered to be "Need to have" for the role.
* Minimum of a BS in life sciences or computer science degree
* Strong Data Management experience in the Biotech/Pharma/CRO industry
Preferred experience/requirements
Below all assets (nice to have) should be presented. Here you can write about personality and good qualities that would be valuable for this role together with relevant experience and other things that can make the candidate more successful in the role.
* Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities
* Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP)
* State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
* Experience of clinical databases, different clinical data management systems and electronic data capture (EDC)
* Demonstrated understanding of clinical data system design / development / validation and system interoperability.
* Demonstrated leadership (including in an outsourced environment)
* Excellent understanding and demonstration of the AZ values and behaviours
* Demonstrated project management skills
* Strong communication and interpersonal skills
* Excellent organizational and analytical skills
* Ability to work independently
* Demonstrated ability to work effectively with external partners
* Ability to negotiate and influence others across functional areas
* Excellent written and verbal communication skills
* Effective problem and conflict solving skills
* Ability to work in a global team environment
* Ability to interact effectively with all levels of management
* High attention to detail and accuracy
More information
Clear instructions about where to turn for more information and last day to apply. Contact details should be Hiring Manager 's name and telephone number.
For more information about the position please contact: Per Haglund, Associate Director Data Management, based in Gothenburg Sweden, at +46 31 7762893.
Welcome with your application no later than 31 January 2018.
AstraZeneca is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2018-01-17ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2018-01-31
Ange följande referens när du ansöker: R-020909
Klicka på denna länk för att göra din ansökanKontaktAstraZeneca
daniela.borquez@astrazeneca.comFöretagAstraZeneca
AdressAstraZeneca
43183
43183 1480
KontorsadressPepparedsleden 1
Jobbnummer 3909636
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