Trial Data Manager

A Swiss pharmaceutical company is looking to hire a Trial Data Manager on an initial 12 month contract. 

Working in a hybrid capacity close to Basel, the successful candidate will have the following responsibilities:

• Ensures that Data Management (Biometry) activities adhere to company standards, and applicable regulations

• Meets study timelines in terms of Data Management deliverables

• Ensures data handling consistency within allocated study(ies)
• 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 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
• Manages and is accountable for Data Management activities in studies where Data Management is outsourced (insourcing/outsourcing partners’ management)
• 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
• 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 handles according to protocol, applicable Quality System (QS) documents and GCP

Candidate Requirements:

• 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

PLEASE NOTE: THIS ROLE IS ONLY OPEN TO EU/EFTA CITIZENS OR THOSE WITH A VALID SWISS WORK PERMIT