Job Description
Company Description
Ergomed Group is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease.
Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia
Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.
We have nourished a true international culture here at Ergomed.
We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description
- 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
Qualifications
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.
Additional Information
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.
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