Our client, a high‑potential biopharmaceutical company headquartered in Switzerland, is looking for a Trial Data Manager for an initial 24‑month contract based in the Basel area.
Trial Data Manager leads Data Management activities for assigned trials and ensures compliance with standards, regulations, and timelines. The role coordinates eCRF development, data review and query management, database lock, and SDTM deliverables. It includes collaboration with Clinical Development stakeholders, overseeing documentation and quality control, and managing outsourced partners when applicable. The position also forecasts resources, ensures team training, and assumes Data Manager responsibilities when required.
Main Responsibilities:
Ensures that Data Management (Biometry) activities for assigned trials adhere to company standards and applicable regulations
Meets trial timelines in terms of Data Management deliverables
Ensures data handling consistency within allocated trials
Leads Data Management activities for assigned trials
Provides Data Management input to the development of the trial protocol
Coordinates the development of eCRFs in line with company standards
Writes all trial Data Management documents covering specifications for external data transfer, data cleaning, and review tools for the Data Management Programmer(s)
Prepares and archives Data Management trial documentation
Organizes, monitors, and tracks the testing of data entry screens (eCRF layout), data cleaning/review tools, and their implementation in the production environment
Organizes, monitors, and tracks data cleaning, data review, query management, and database lock; ensures processes are driven in collaboration with key Clinical Development stakeholders
Generates trial metrics and status reports
Represents Data Management at Clinical Trial Team meetings
Presents trial‑related topics at CTT, investigator, and monitor meetings
Manages and is accountable for Data Management activities in studies where Data Management is outsourced
Participates in development and review of policies, SOPs, and associated documents for Data Management
Represents Data Management in cross‑functional working groups related to the system/process
Forecasts trial team resource requirements
Ensures Data Managers assigned to trials have required training
Ensures annotated CRFs are created, validated, and provided as per agreed timelines
Performs and/or coordinates quality control (QC): periodic operational checks to verify that clinical data are handled according to protocol, applicable quality system documents, and GCP
Acts as Data Manager for studies where no DM is assigned
Qualifications and Experience:
Relevant Swiss working/residency permit and/or Swiss/EU citizenship required.
A master’s degree in life sciences, mathematics, statistics, informatics or related disciplines is required.
3+ years of experience in the pharmaceutical or biotech industry within clinical research and/or clinical data management with a strong functional expertise in Data Management.
Strong organizational and communication skills in English.
Good knowledge of international clinical research regulations and requirements (e.g., ICH GCP).
Experience in clinical trial databases and applications, clinical data flow, data review, and eCRF design.
Ability to lead and coordinate the activity of Data Manager(s) allocated to the same trial.
Good organizational and presentation skills.
Fluent in written and spoken English.
Sedentary – minimal handling of light materials and tools, lifting up to 10 lbs. May involve walking or standing for brief periods of time.
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