The Life Science Career Network 

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

 

Our client is 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, with the aim of transforming the horizon of therapeutic options is looking a Trial Data Manager for a initial 24 months contract based in 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. The role includes collaboration with Clinical Development stakeholders, overseeing documentation and quality control, and management of 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 (related to assigned trial) adhere to the company Standards, and applicable regulations
  • Meets trial timelines in terms of Data Management deliverables
  • Ensures data handling consistency within allocated trial(s)
  • Leads Data Management activities for assigned trial
  • Provides Data Management input to the development of the trial protocol
  • Coordinates the development of the (e)CRF in line with the company standards
  • Writes all trial 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 trials(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; makes sure processes are driven in collaboration with key Clinical Development (CD) stakeholders
  • Generates trial metrics and status reports
  • Represents Data Management at Clinical Trial Team (CTT) meetings
  • Presents trial related topics at CTT, Investigators and Monitors meetings
  • Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners’ management)
  • 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 trial team resource requirements
  • Ensures Data Managers assigned to trial have required training
  • Ensures annotated CRF is 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 
  • 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 pharmaceutical or Biotech industry within Clinical Research and/or Clinical Data Management with a strong level of functional expertise in Data Management is required.
  • Strong organizational and communication skills in English.
  • 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 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

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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