Senior Clinical Data Manager (m/w/d)

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.