Beschreibung
Wir, die Accessio IMS, suchen ab 01.07.2021 für unseren Kunden einen Freelancer Data Management Experte (m/f/d) in Vollzeit für ca. 6 Monate am Standort Raum Darmstadt und Remote.Vor Ort Einsatz: 5%
Mandatory skills:
- Data Management expertise in outsourced trials (CRO surveillance)
- Oncology and/or Neurology experience
- SDTM basic knowledge
- External data handling QC (reconciliation, independent read, central lab)
- Data review (SAS datasets)
- strong English language skills
Preferred skills:
- SAS/R programming
- Vendor management (Oncology, PK, PD, central lab)
- Pinncacle21
- Inform/RAVE
Your Role:
Providing project management expertise working with CRO data managers, key decision makers, and internal team members to manage all Data Management related activities in a clinical development program, issue escalation and provide technical expertise. Supervising surveillance of CRO activities regarding the quality and timeliness of the deliverables and ensure database is ready for lock and potential submission (FDA, EMA, PMDA, CFDA, etc.). Providing justification for and perform direct negotiations with CRO's (e.g., timelines, process and resources). Provide leadership to identify root causes of issues and implement remedial actions. Ensure service and quality meet agreed upon specifications per the Integrated Data Management Plan and contract/scope of work.
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