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Trial Data Manager

Trial Data Manager

CK GroupAllschwil
Vor 30+ Tagen
Stellenbeschreibung

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