
Trial Data Manager
- Allschwil, Bâle-Campagne
- Contrat
- Temps-plein
- Ensure all data management activities for assigned studies meet company standards and regulatory requirements.
- Lead data management tasks, including protocol input, eCRF development, and data handling consistency.
- Write and oversee study documentation, such as specifications for data transfer, cleaning, and review tools.
- Coordinate testing and implementation of data entry screens, eCRF layouts, and review tools.
- Manage data cleaning, query resolution, and database lock processes in collaboration with clinical development teams.
- Generate study metrics and status reports while representing data management in clinical trial team meetings.
- Oversee outsourced or insourced data management activities and ensure proper documentation and archiving.
- Participate in the development and review of policies, SOPs, and related documents.
- Forecast resource needs and ensure team members receive necessary training.
- Deliver Study Data Tabulation Model (SDTM) datasets, annotated CRFs, and related outputs on time.
- Perform quality control checks to ensure compliance with protocols, quality systems, and GCP standards.
- Degree in life sciences, mathematics, statistics, informatics, or a related field.
- Strong knowledge of clinical research regulations, including ICH-GCP guidelines.
- Experience with clinical trial databases, data flow, data review, and eCRF design.
- Ability to lead and coordinate data management activities across studies.
- Excellent organizational, communication, and presentation skills.
- Proficiency in written and spoken English.
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