Lead Data Manager

Summary

Join Ergomed Group, a thriving CRO specializing in Oncology and Rare Disease, as a Lead Data Manager. You will oversee all data management aspects of projects, from start-up to database lock, collaborating with various functional groups. Reporting to the Director of Data Management, you will provide updates, metric reports, and training to team members. Responsibilities include authoring/reviewing data management documentation, supporting EDC design and testing, creating reports, managing project files, and performing data review and reconciliation. The ideal candidate possesses 3-5 years of relevant experience in the pharmaceutical industry or CRO, proficiency in EDC systems, and strong computer skills. Ergomed offers training, career development, a supportive environment, and opportunities for global collaboration.

Requirements

• 3-5 years of relevant experience in pharmaceutical industry and/or contract research organization, specifically in data management
• Experience in working with EDC systems (e.g. Merative Zelta, Medrio, Medidata RAVE, iMednet, Datatrial)
• Proficiency in computer applications: Windows, Excel, Word, Outlook etc

Responsibilities

• Provide updates for Data Management during internal/client team meetings and communication if required
• Provides metric reports for internal/external project team
• Meets with the Project Manager to work on completing the study objectives in a timely manner
• Provides training of other DM staff on project specific processes
• Provides feedback to other project team members and managers to improve the deliverables
• Authors or reviews data management documentation including the Data Management Plan, Data Review Plan, eCRF Completion Guidelines, and others as needed
• Supports design and testing of EDC study designs
• Creates listings/reports using ad hoc reporting tools across multiple EDC systems
• Communicates any project risks or possible quality issues to the Project Manager
• May work on projects across multiple trial EDC platforms
• Maintains project files and ensures full traceability of all processes and documentation
• Manages Lab ranges across the entire study
• Performs data management activities such as data review, serious adverse event reconciliation, third party electronic data (e.g. laboratory, PK, diary) reconciliation, and query management
• Oversees the issuing of queries and reviews query responses with the highest level of quality

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language