Senior Clinical Data Manager | Medidata Rave Expert

Cytel; Polska; On-site; PLN 180,000 - 260,000; Full time

Job summary

Cytel is seeking a Senior Clinical Data Manager to provide comprehensive data management support for assigned clinical studies in Poland. You will perform ongoing data review, ensure data accuracy, and support data cleaning activities in collaboration with cross-functional teams.

The role requires a minimum of four years of clinical data management experience and proficiency in Medidata Rave, with strong knowledge of GCP, FDA and ICH guidelines.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or related field.
• Minimum of 4 years of clinical data management experience.
• Hands-on data review experience in clinical trials.
• Proficiency in Medidata Rave (build knowledge a plus, but not required).
• Strong understanding of regulatory requirements (GCP, FDA, ICH).

Responsibilities

• Perform ongoing review of clinical trial data to ensure accuracy, completeness, and consistency.
• Identify, investigate, and resolve data discrepancies through query management.
• Conduct manual and system-driven data reviews in accordance with study protocols and DMPs.
• Collaborate with cross-functional teams to support data cleaning activities.
• Participate in database lock activities and ensure data readiness for analyses.
• Maintain study documentation in compliance with regulatory requirements and SOPs.
• Manage user access within clinical data management systems (e.g., Medidata Rave).
• Process access requests and ensure appropriate role-based permissions.

Skills

Clinical data management

Data review

Regulatory knowledge

Education

Bachelor’s degree in Life Sciences or related field

Tools

Medidata Rave

Job description

Cytel is seeking a Senior Clinical Data Manager to provide comprehensive data management support for assigned clinical studies in Poland. You will perform ongoing data review, ensure data accuracy, and support data cleaning activities in collaboration with cross-functional teams.

The role requires a minimum of four years of clinical data management experience and proficiency in Medidata Rave, with strong knowledge of GCP, FDA and ICH guidelines.