SDC activities - Clinical Scientist (Clinical Affairs)

Roles & Responsibilities:

Study Data Cleaning (SDC)

• Perform Study Data Cleaning (SDC) activities for clinical investigations, registries, and PMCF studies.
• Review clinical databases for completeness, consistency, and accuracy.
• Identify, investigate, and resolve data discrepancies and data queries.
• Support ongoing data review and reconciliation activities.
• Ensure data quality standards are maintained throughout study conduct.

Clinical Data Review & Validation

• Conduct medical and scientific review of clinical study data.
• Review adverse event, device deficiency, protocol deviation, and endpoint-related data.
• Collaborate with clinical sites and data management teams to resolve data issues.
• Support database lock activities and data validation processes.

Clinical Research Support

• Assist with clinical study conduct and data review activities.
• Support development and maintenance of data review plans.
• Participate in study team meetings and review clinical metrics.
• Ensure compliance with study protocols and applicable regulations.

Cross-Functional Collaboration

• Work closely with Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory Affairs teams.
• Support preparation of study reports and clinical evidence documentation.
• Provide scientific input during clinical data review discussions.
• Contribute to continuous improvement initiatives related to data quality and study execution.

Quality & Compliance

• Ensure compliance with EU MDR, ISO 14155, GCP, and internal quality procedures.
• Maintain complete and audit-ready documentation.
• Support internal audits, inspections, and quality reviews as required.

Skills & Qualifications:

Mandatory

• Proficiency in Clindex.
• Experience in Study Data Cleaning (SDC) activities.
• Understanding of clinical data review and reconciliation processes.
• Knowledge of clinical research principles and study conduct.
• Strong data review, analytical, and problem-solving skills.
• Proficiency in Microsoft Excel and clinical database systems.

Preferred

• Knowledge of EU MDR, ISO 14155, and GCP.
• Experience with EDC systems and clinical databases.
• Familiarity with PMCF studies, registries, and clinical investigations.

Understanding of biostatistics and clinical endpoints.