• Provide technical supervision in the development of data management plans (DMP), data validation specifications (DVP), CRF development and other data management documents (DTS…)
• Coordinate interactions between suppliers and project teams related to DM activities (data transfer agreements, specification documents, etc.).
• Review and approve specifications and documents related to EDCs, including the execution and approval of UATs.
• Review all relevant DM documents (annotated CRF, data validation plan, data transfer specifications, reconciliation plans)
• Coordinate interactions related to DM activities between suppliers and project teams (data transfer agreements, specification documents, etc.)
• Ensure that activities leading to database locking are tracked and documented (reconciliation of EIGs, review, approval of data coding, etc.).
• Facilitate team review and resolution of technical issues requiring clinical and/or regulatory input.
• Oversee the design and development of the EDC system
• Ensure that the eTMF is maintained
• Oversee the implementation and maintenance of project schedules
• Ensuring the performance of our data management partners in all projects
• Contribute to the improvement of biometric processes.
• Know and respect the GEHC quality manual, the quality management system, the quality management policy, the quality objectives and the applicable laws and regulations as they apply to this type of job/position.
• Complete all scheduled Quality and Compliance training within the defined deadlines.
• Identify and report any quality or compliance issues and take immediate corrective action if necessary.
• Ensure data integrity.
• Supporting compliance of deliverables with regulatory requirements.

Basic qualifications

• At least 10 years of experience in clinical data management with a minimum of 5 years in EDC, preferably in at least one of the following systems: Medidata Rave, Ennov, Veeva Vault
• Minimum Bachelor's degree (Bac +3) in science or a related field
• Experience with Oracle Clinical, Medidata Rave, Oracle InForm, or similar clinical systems
• Solid experience in all aspects of DM processes (UAT, data cleansing, defining controls, data review, managing data transfers, reconciliations)
• Significant knowledge in CDISC-SDTM
• Experience in eCRF design and SAS programming is a plus
• Practical knowledge of regulatory guidelines for good practices (GCDMP, ICH…)
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