S seeking a Trial Data Manager to join a pharmaceutical organization in Allschwil. In this role, you will oversee data management activities for clinical studies, ensuring compliance with company standards and regulations. You will play a key role in managing data processes, coordinating with cross-functional teams, and delivering high-quality data outputs within set timelines.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
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.
Key Skills and Requirements:
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.
For more information, please contact Antonia Ray .
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