Beschreibung
Wir, die Accessio IMS, suchen ab dem 09. August 2021 für unseren Kunden einen Freelancer Data Manager with SAS expertise (m/f/d) für ca. 5 Monate am Standort Raum Darmstadt.Auslastung: 80% vor Ort, 20% Remote
Fokus should be on:
Data Manager with SAS expertise or SAS Programmer
Expertise in setting up Data Transfer Specifications for Non-CRF data (e.g. laboratory data)
SDTM expertise
Overall tasks:
• Ensures external/Non-CRF data standards across clinical development programs
• Independently performs Biosample Lab Data Management tasks in a timely manner, in compliance with the existing processes, the regulatory constraints and the needs of the department and global development projects.
• Develops and reviews specifications related to external/NON-CRF data management (e.g. Lab Data Management), such as data transfers, relevant sections in analysis protocols, clinical trial protocols, Informed Consent Forms
• Coordinates and performs data transfers with other functions (internal and external/collaboration partners)
• Ensuring proactive management of risks associated with non-CRF data integration in alignment with PDM/TDM
• Performs external/non-CRF data validations, including exhaustive checks, quality control, conformity to specifications, data cleaning
• Delivers data releases and reports to other functions, relevant sections of biomarker study reports and to the Clinical Database, integrating experimental data and clinical data
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