Senior Clinical Data Manager

Cytel; Poland; On-site; PLN 180,000 - 240,000; Full time

Job summary

Cytel is seeking a Senior Clinical Data Manager to provide comprehensive data management support for assigned clinical studies. The role focuses on data review to ensure accuracy, completeness, and consistency with the protocol and data management plan.

The candidate should have at least four years of clinical data management experience, hands-on data review in trials, and proficiency in Medidata Rave. Knowledge of GCP, FDA, and ICH guidelines is essential.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or a 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 clinical data management processes and regulatory requirements (GCP, FDA, ICH).
• Experience with query management and discrepancy resolution.

Responsibilities

• Perform ongoing review of clinical trial data for accuracy and completeness.
• Identify, investigate, and resolve data discrepancies via query management.
• Conduct manual and system-driven data reviews per study protocols and DMPs.
• Collaborate with Clinical Operations, Biostatistics, Programming, Medical Monitoring to support data cleaning.
• Participate in database lock activities and ensure data readiness for analyses.
• Maintain study documentation in compliance with regulatory requirements and SOPs.
• Manage and maintain user access within data management systems (e.g., Medidata Rave).
• Process access requests, modifications, and terminations per procedures.
• Ensure appropriate role-based access and system permissions are assigned.
• Maintain audit-ready documentation related to user access activities.
• Support periodic access reviews and compliance checks.
• Assist with system user training and troubleshooting as needed.

Skills

Data review

Query management

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences / Health Sciences / related field

Equivalent experience

Tools

Medidata Rave

Job description

The Senior Clinical Data Manager will provide comprehensive data management support for assigned clinical studies. The SCDM will be responsible for performing ongoing data review to ensure accuracy, completeness, and consistency of clinical trial data in accordance with the study protocol and data management plan. The CDM will have a minimum of four years of clinical data management experience, including hands-on data review experience, and demonstrated proficiency in Medidata Rave.

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 (Clinical Operations, Biostatistics, Programming, Medical Monitoring) to support data cleaning activities.
• Participate in database lock activities and ensure data readiness for interim and final analyses.
• Maintain study documentation in compliance with regulatory requirements and internal SOPs.
• Manage and maintain user access within clinical data management systems (e.g., Medidata Rave).
• Process access requests, modifications, and terminations in accordance with established procedures.
• Ensure appropriate role-based access and system permissions are assigned.
• Maintain audit-ready documentation related to user access activities.
• Support periodic access reviews and compliance checks.
• Assist with system user training and troubleshooting as needed.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field (or equivalent experience).
• Minimum of 4 years of clinical data management experience.
• Demonstrated hands-on data review experience in clinical trials.
• Proficiency in Medidata Rave (build knowledge a plus, but not required).
• Strong understanding of clinical data management processes and regulatory requirements (GCP, FDA, ICH guidelines).
• Experience with query management and discrepancy resolution.