Description
- Supporting Data Management including centralized monitoring related activities within a complete clinical development program (Phase I-IV, Accountable and Project Leadership) for global or regional trials and/or programs with different complexity
- Basic knowledge of Clinical Data Management related topics
- Hasbasicorganizationaland relevant marketknowledgeandusesunderstandingonhow relevant areascanbeintegratedtoachieveobjectives.
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Ensures and tracks data quality of clinical database/deliverables (incl. CRF and non-CRF data) of the clinical data management deliverables and data packages (e.g. CDISC) -
Executionoftheclinicaldatacollectionstrategy in accordancetotheCompanys Standards (Data Collection, SDTM (CDISC)) asapplicable -
Support oversight of CROs in the execution of Phase I - IV clinical trial(s) by leveraging existing tools as well programming of customized reports using SAS or R.
- Support the successful execution, oversight and approval of all DM related clinical trial documents and operational plans (e.g. Data Management Plan) of clinical trials
- Filters, prioritizes, analyzes and validates complex and information from a diverse range of external and internal sources to respond to technical operational and organizational challenges
- Supports the development and implementation of department initiatives including input on SOPs, processes, and work-streams
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Support Trial- and Program Data Manager in projects/work streams with moderate complexity, risk, impact and reach. Impacts medium-sized global project teams with members also from outside the direct working environment. Coordinates stakeholders from closely related areas or even beyond -
Support oversight of CROs in the execution of Phase I - IV clinical trial(s) by leveraging existing tools as well programming of customized reports using SAS or R. -
Demonstratesskills in successfullysupporting international teams in thematrixorganizationanddirect, influenceandmotivatepeople; contributesto a positive workingclimate -
Coordinates operational and therapeutic area training for internal and external study team members. - Supporting successful project execution including definition of milestones. May also include clarification of project scope. Receives minimal guidance or works independently.