Trial Data Manager
Job Title: Trial Data Manager for Biometry
Work Location: Allschwil
Country: Switzerland Schedule: Fulltime (100%)
Desired start date: ASAP
Duration: 12 months
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 for
external data transfer, data • cleanings and review tools that will be further provided to DATA
MANAGEMENT PROGRAMMER(S) for • development for the allocated study(ies) • 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; 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 studies
where 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 Operating
Procedures (SOPs), and associated • documents for Data Management • Represents Data Management in cross functional working groups related
to 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 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 (QS) documents
and GCP • Work is expected to be performed on the premises of Viatris • Acts as DATA MANAGER for studies where no DM is assigned
REQUIRED 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