25 km
(Senior) Clinical Data Manager (m­­/­­f­­/­­d) 12.11.2021 Merz Aesthetics Frankfurt
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(Senior) Clinical Data Manager (m/f/d)
Frankfurt
Aktualität: 12.11.2021

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12.11.2021, Merz Aesthetics
Frankfurt
(Senior) Clinical Data Manager (m/f/d)
You define trial specific data management procedures in Data Management Plans You coordinate (e)CRF development, administration and updates, including eCRF User Acceptance Tests and definition of User Roles and User Administration Procedures You define trial specific edit checks and discrepancy management procedures in Data Validation Plans You organize and specify transfers of data collected outside of the eCRF (e.g. ePROs) You define the content of regular status reports and distribute them You oversee medical coding using MedDRA and WHO-DD You conduct and oversee SAE reconciliation and resolution of resulting discrepancies You coordinate database freezes and close activities You optimize and update data management processes to reflect possible changes in regulatory requirements You oversight CRO performance of data management activities, including participation in CRO selection, reviews, QC measures, and data transfers Strategic and analytical thinking Collaboration in multi-functional and global teams
Ideally at least 3 years experience in Clinical Data Management Business fluent in English (written and spoken) Experience with EDC systems, ideally experience with SAS and CDISC data standards Excellent communicating and team player skills High sense of responsibility and quality awarenessess Analytical and highly structured way of working

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