Trial Data Manager

vor 6 Stunden

Basel, Schweiz CTC Resourcing Solutions Vollzeit

Trial Data Manager – 6233 URA

Our client, headquartered in Switzerland – a biotech hub of Europe – is a high-potential biopharmaceutical company specialized in the discovery, development, and commercialization of innovative small molecules. They are looking for a Trial Data Manager for an initial 12-month contract based in the Basel area.

Main Responsibilities:

  • Ensures that Data Management (Biometry) activities (related to assigned study) adhere to Company 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 Company standards.
  • Writes all study Data Management documents covering specifications for external data transfer, data cleaning, 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. Ensures 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 the 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 the 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 the Company.
  • 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;
  • 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 a 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.
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