Data Manager - Switzerland - Hybrid Working - 12 month contract - 1 FTE
Location | Allschwil |
Discipline: | Biometrics |
Job type: | Contract |
Salary: | £61.01 - 69.49 DOE |
Contact name: | Harry Henson |
Contact email: | harry.henson@rbwconsulting.com |
Contact phone: | +44 (0)1293 364 092 |
Job ref: | 31972D |
Published: | 8 months ago |
Duration: | 12 months |
Expiry date: | 29 May 2024 10:59 |
Startdate: | ASAP |
RBW Consulting are partnering with a leading Biopharmaceutical organisation in their search for a Data Manager on a 12 month contract in Switzerland. This company discovers, develops, and commercializes medicines across a wide variety of therapeutic areas.
This role will be a 12 month, 1 FTE contract and it will be hybrid working with 3 days office based in Allschwil and 2 days working from home. The hourly rate on offer is in the range CHF 61.01 - 69.49 DOE.
Job Requirements
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 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 handles according to protocol, applicable Quality System (QS) documents and GCP
Acts as Data Manager for studies where no DM is assigned
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
Please apply here and Harry Henson will be in touch to discuss your application in more detail.
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