Amaris is looking for a Data Manager with strong experience in clinical data management for CRO environments. The position focuses on supervising data management activities to ensure the smooth progress and quality of clinical projects.

- Act as the main point of contact for all data management topics and participate in project/study meetings
- Contribute to the selection of subcontractors by preparing specifications and evaluating proposals
- Participate in study design, including data management sections in protocols and CRF specifications
- Oversee outsourced data management activities, ensuring compliance with cost, timelines, and data quality
- Validate deliverables such as data management plans, validation plans, transfer specifications, eCRF completion guides, and coding instructions
- Test eCRF before production deployment and after each protocol amendment
- Implement targeted quality control of data based on risk assessment
- Monitor progress of data management steps (entry, cleaning, coding,



external data transfers, SAE reconciliation, etc.)
- Approve SDTM specifications and verify SDTM packages as needed
- Regularly assess subcontractor service quality, establish action plans for deviations, and discuss corrective measures
- Participate in data review meetings and validate associated reports
- Ensure responsibility for database lock and unlock, verifying all prerequisites
- Provide statisticians with data for statistical analysis
- Verify the presence of all data management documentation in the Trial Master File (TMF)
- Experience in clinical data management for CROs (5–10 years)
- Proficiency with industry-standard data management tools and software
- Academic background in Life Sciences, Pharmacy, or related field
- English fluent. French is a plus.
- You demonstrate strong analytical and problem-solving skills

📌 Clinical Data Manager (F/M/X) (Barcelona)
🏢 Amaris Consulting
📍 Barcelona