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.
- Solid 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)
🏢 Alkem MedTech
📍 Mumbai