Trial Data Manager

Job title:

Trial Data Manager

Company

CK Group

Job description

RESPONSIBILITIES AND TASKS Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Viatris Standards, and applicable regulations

• Meets study timelines in terms of Data Management deliverables • Ensures data handling consistency within allocated study(ies) • Leads Data Management activities for assigned study • Provides Data Management input to the development of the study

protocol • Coordinates the development of the (e)CRF in line with Viatris standards • Writes all study Data Management documents covering specifications forexternal data transfer, data • cleanings and review tools that will be further provided to DATAMANAGEMENT PROGRAMMER(S) for • development for the allocated study(ies) • Organizes, monitors, and tracks the testing of data entry screens (eCRFlayout), data cleaning / review tools, • and their implementation in the production environment • Organizes, monitors, and tracks data cleaning, data review, querymanagement, and database lock; makes • sure processes are driven in collaboration with key Clinical Development(CD) stakeholders • Generates study metrics and status reports • Represents Data Management at Clinical Trial Team (CTT) meetings • Manages and is accountable for Data Management activities in studieswhere Data Management is • outsourced (insourcing/outsourcing partners’ management) • Prepares and archives Data Management study documentation • Presents study related topics at CTT, Investigators and Monitors meetings • Participates in development and review of policies, Standard OperatingProcedures (SOPs), and associated • documents for Data Management • Represents Data Management in cross functional working groups relatedto the system / process • Forecasts study team resource requirements

• Ensures Data Managers assigned to study have required training • Ensures Study Data Tabulation Model (SDTM) deliverables (Including

SDTM datasets, define.xml and • annotated CRF) are created, validated, and provided as per agreedtimelines • Performs and/or coordinates Quality Control (QC): Periodic operationalchecks to verify that clinical data are • handled according to protocol, applicable Quality System (QS) documentsand GCP • Work is expected to be performed on the premises of Viatris • Acts as DATA MANAGER for studies where no DM is assignedREQUIRED QUALIFICATIONS AND EXPERIENCE

• Recognized degree in life sciences, mathematics, statistics, informatics, or related disciplines

• At least 3 years’ experience in Pharmaceutical or Biotech industry within Clinical Research and / or Clinical Data Management with good level of functional expertise in Data Management

• Good knowledge of international clinical research regulations and requirements (e.g., International Conference on Harmonization – Good Clinical Practice (ICH/GCP))

• Experience in clinical trial databases and applications, clinical data flow, data review, and (e)Case Report Form (CRF) design

• Ability to lead and coordinate the activity of DATA MANAGER(S) allocated to his/her study

• Good organizational and presentation skills • Fluent in written and spoken English

Expected salary

Location

Allschwil, Bâle-Campagne

Job date

Sat, 30 Nov 2024 05:37:04 GMT

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