Lead Data Manager (Expert in working & developing EDC systems)

• The Lead Data Manager (LDM) within the ERGOMED Data Management (DM) department is responsible for providing oversight of all DM parts of a project from study start-up to database lock by working in a collaborative team environment with all functional groups.
• The Lead Data Manager represents a position under direction of the Director of Data Management.
• 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 build, 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
• Perform DM and/or EDC activities if needed, provided the required experience and background are in place

3-5 years of relevant experience in pharmaceutical industry and/or contract research organization, specifically in data management.

Experience in working with and developing EDC systems (e.g. Merative Zelta, Medrio, Medidata RAVE, iMednet, Datatrial) · Proficiency in computer applications: Windows, Excel, Word, Outlook etc.

Medidata RAVE and/or Zelta Certification is an asset.

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.  

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

 We offer: 

• 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 

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!  

Quality 

Integrity & Trust  

Drive & Passion  

Agility & Responsiveness  

Belonging 

Collaborative Partnerships  

We look forward to welcoming your application. 

#LI-Remote