Clinical Data Manager H/F
il y a 2 semaines
Key Responsibilities:
We are seeking a highly skilled Data Management Expert to join our team at Ividata Life Sciences. As a key member of our Clinical Data Management team, you will be responsible for ensuring the smooth execution of clinical trials.
Key Accountabilities:
- Act as the primary point of contact for client Data Management for any study, ensuring projects meet study timelines and representing Data Management at Study Team meetings/client meetings.
- Support the build and testing of EDC databases through go-live, ensuring seamless data collection and management.
- Drive, organize, monitor, and track ongoing data cleaning, data review, discrepancy management, and data extractions for review committees, interims, and database lock.
- Support the design and programming of eCRFs using CDASH and SDTM output, ensuring data quality and integrity.
- Develop, review, and approve study Data Management documents using agreed templates per Ividata Group standards.
- Manage external data, including preparation of Data Transfer agreements, data reconciliation, loading, secure storage, and archiving per client requirements.
- Review and generate study metrics and status reports within and across several studies, providing valuable insights to stakeholders.
- Oversee vendor management and client service providers' DM activities, ensuring compliance and quality.
Requirements:
- Higher education (BSc, MSc, PhD in life sciences or technical)
- At least one year DM experience for Data Manager, 3+ years for lead Data Manager
- Proficient in one of the leading Data Management systems: Veeva CDMS, Medidata RAVE, Oracle
- Good level of English (written and oral)
- Soft skills: Autonomy, teamwork, interpersonal skills, and leadership
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