Data Manager

Docs International / Datajobb / Solna
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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.

Publiceringsdatum
2016-11-22

Så ansöker du
Sista dag att ansöka är 0001-01-01

Kontakt
Företag
Docs International

Adress
Docs International
16973 SOLNA

Kontorsadress
Gustav III.s Boulevard 34

Jobbnummer
3175468

Observera att sista ansökningsdag har passerat.

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