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.
Robust 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.

📌 Sdc Activities Clinical Scientist Clinical Affairs Mumbai (India)
🏢 Alkem MedTech
📍 India