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. Responsibilities include providing data management updates, creating metric reports, training staff, reviewing documentation, supporting EDC design and testing, and managing lab ranges. You will also perform data review, query management, and ensure data quality. The role requires 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