Clinical Data Manager

(60–100%)

We are looking for a dynamic, committed and goal-oriented person to join our Data Team as Clinical Data Manager to manage DCB’s cloud-based data infrastructure.

Responsibilities

• Create and maintain cloud-based REDCap server instances
• Set up and maintain study eCRFs
• Train and support the clinical study team to use the EDC system
• Develop data management plans and support clinical trials according to standard operating procedures (SOPs) and ICH-GCP guidelines
• Write, review, and approve study data management documents
• Conduct data query resolution procedures and data extractions for review committees, interims, and database lock
• Review and generate study metrics and status reports
• Manage external data including data reconciliation, loading, and archiving per client requirements
• Manage IT service providers
• Represent Data Management at both internal and external meetings
• Support programming for statistical analysis

Qualifications

• Higher education (MSc. in life sciences or technical)
• At least 3-5 years data management experience in the medical device or pharmaceutical industry, or within CROs
• Proficient in at least one leading EDC system
• Hands-on experience in cloud-based data solutions
• Knowledge of clinical trials phase 1 through post marketing
• Knowledge of current data management standards would be an advantage (i.e., CDISC, FAIR)
• Professional level of English (written and oral)

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