Data Manager
Docs International / Datajobb / Solna
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hela Sverige Support clinical studies and projects by managing all clinical data management activities including:
• Ensure high quality data management support for projects through the evaluation of CRO suppliers, and provide input into outsourcing strategy and processes.
• Ensure that the appointed CROs SOPs and data management processes are in agreement with client's requirements.
• Provide data management input to relevant strategic study documents (e.g. study protocol) and vendor contracts.
• Work as a member of the Clinical Team to establish, communicate and deliver on a clinical data handling strategy and plan.
• Create or ensure development of relevant Data Management documentation (i.e. Data Management Plan).
• Create or ensure development of data transfer agreements with external vendors.
• Ensure data delivered to Client is in accordance with Client's requirements and standards.
• Ensure that defined data deliverables for in-licensed projects are transferred in accordance with Client's requirements and standards, and to evaluate completeness and quality of the delivered data.
• Coordinate data deliverables and adherence to relevant government guidelines in preparation for submission.
• Validate or review study data in CDISC format using available tools according to Client standard.
Support and drive project- and company standards:
• Coordinate, develop and maintain Client's internal project data standard.
• Coordinate, develop, maintain and implement Client's internal process to adapt to CDISC standard.
• With insight in CDISC data standards and in company- and project needs, in collaboration with CRO, review and define study data mappings.
Support and drive enablement and finalization of regulatory submissions:
• Review, update or prepare regulatory delivery documents (e.g. define.xml)
Support and drive projects related technical equipment:
• Ensure new data system(s) and new technical tools/equipment(s) to be used are in compliance by following the established guidelines of national and international regulatory authorities.
Overall accountable for Clinical Data Management services within Biostatistics/Data Management & Medical Writing department including:
• Clinical data management systems and processes.
• Quality and location of Client's clinical data.
• Clinical data management support in development projects, as well as product support.
• Project coordination of all data management work in the project,
• Provide a high level of expertise in data management overall within Client and with external contacts.
Education/Learning Experience
Required:
• University degree in Life/Health Science,/Computer Science or
• Long Experience within Life/Health Science/Computer Science or other relevant areas.
Work Experience
Required:
• At least 1 year experience of drug development including computer applications, database systems and clinical development/clinical data management.
• Experience of regulatory submission in CDISC format.
Skills/Knowledge
Required:
• Familiar with CDISC conventions, i.e. SDTM and ADaM models and controlled terminology, and experience implementing and using these models.
• Familiar with common external coding dictionaries (e.g. MedDRA, WHO DD).
• Excellent skills in writing Data Management specific documents (e.g Data Management Plans).
• Excellent skills in written and oral communication.
• Demonstrated project leadership experience.
• Demonstrated ability to find innovative approaches.
• Strong individual initiative and organizational skill.
Desired:
• Knowledge in CDISC data standards and controlled terminology.
Personal Attributes
Required:
• Demonstrated ability to work independently, strong individual initiative.
• Demonstrated ability to work in a team environment, collaborative.
• Demonstrated focus on details.
• Organisation skill and multi-tasking abilities.
• Highly developed respect for timelines; serves as a role model for completing tasks and delivering on commitments in a timely manner.
• Curiosity and drive to broaden skill and knowledge.
Languages
Required: English, both oral and written communication.
Desired: Swedish, both oral and written communication
Varaktighet, arbetstid
Fast anställning hos DOCS men du blir uthyrd till ett läkemedelsföretag i Solna.
Publiceringsdatum2016-11-22Så ansöker duSista dag att ansöka är 0001-01-01
KontaktFöretagDocs International
AdressDocs International
16973 SOLNA
KontorsadressGustav III.s Boulevard 34
Jobbnummer 3175468
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