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Senior clinical data manager (m/w/d)

Frankfurt am Main
SThree Germany
Manager
65.000 € - 75.000 € pro Jahr
Inserat online seit: 14 April
Beschreibung

Clinical Data Manager (m/w/d) The following responsibilities are awaiting you: You define all trial‑specific data management procedures, including the Data Management Plan, Data Validation Plan, and related documentation. You coordinate the development, administration, updates, and user acceptance testing of both eCRFs and eDiary/eCOA systems, including user roles, rights, and overall user administration. You organize and specify electronic data transfers for all external data sources You define and manage regular data management status reports, including report content and distribution. You oversee medical coding activities using MedDRA and WHO‑DD. You ensure robust safety data reconciliation (SAE/AESI/AEI) and timely resolution of discrepancies. You coordinate database freeze and lock activities, ensuring timelines and data quality expectations are met. You ensure compliant storage and archiving of clinical databases and subject eCRFs/eDiaries. You drive the continuous optimization of data management processes, ensuring alignment with evolving regulatory requirements and strengthening cross‑functional You oversee CRO performance in all data management activities, including participation in CRO selection, quality control measures, reviews, and data What we expect from you: You hold a Master's degree in Documentation, Medical Documentation, Medical Informatics, Bioinformatics, Natural Sciences, or a similar field, and bring at least 3 years of clinical data management experience. You are proficient in Microsoft Office tools and have hands‑on experience with EDC systems and SAS; experience with CDISC standards and ISO 14155 is a You have a strong understanding of ICH, GCP, and FDA guidelines, applying them effectively in daily work. You work analytically, structured, and solution‑oriented, bringing excellent organizational skills and solid project‑management capabilities. You demonstrate resilience, emotional intelligence, and strong problem‑solving skills, and can adapt quickly when priorities shift. You are a strong team‑player with cross‑functional collaboration abilities and can motivate and influence others. You communicate fluently in English and demonstrate excellent written, oral, and interpersonal communication skills. Ist das die Chance, auf die du gewartet hast? Dann sende deinen Lebenslauf über den Bewerbungslink oder per E‑Mail an l.kramer[at]progressive.de. Wenn diese Position nicht zu dir passt, teile sie gern in deinem Netzwerk - wir freuen uns sehr über Weiterempfehlungen! Eine neue Möglichkeit, frische Inspiration und eine Perspektive mit einem starken Partner - Progressive® Jetzt bewerben! SThree_Germany is acting as an Employment Business in relation to this vacancy.

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