Clinical Data Management - Clinical Data Associate

Reqras Research; Hyderabad; On-site; INR 600,000 - 800,000; Full time

Job summary

Reqras Research is seeking skilled professionals in Clinical Data Management (CDM) to join our team in Hyderabad. The role focuses on data management activities for clinical trials, including data review, query management, and database maintenance.

Ideal candidates will have knowledge of CDM processes, CRF/eCRF, EDC systems, and GCP guidelines, with attention to data quality and regulatory requirements. Strong analytical and communication skills are essential.

Qualifications

• Knowledge of CDM processes, data flow, and data handling.
• Understanding of clinical trials and clinical research lifecycle.
• Experience with CRF/eCRF, EDC systems, and query management.
• Familiarity with data review, data validation, and discrepancy handling.

Responsibilities

• Perform clinical data management activities for clinical trials.
• Review and validate clinical trial data for accuracy, completeness, and consistency.
• Perform data entry, data review, and discrepancy management.
• Raise, track, and resolve data queries.
• Support database design, testing, validation, and maintenance.
• Perform medical coding and reconciliation activities, as applicable.
• Work on clinical data cleaning and database lock activities.
• Ensure compliance with CDISC standards, SOPs, and regulatory guidelines.
• Coordinate with clinical operations, medical coding, and other project teams.
• Maintain data quality and meet project timelines.

Skills

CDM processes

Clinical trials

CRF/EDC systems

Data validation

GCP & regulatory

Analytical/communication

CDISC SDTM/ADaM

Education

Bachelor's or Master's in Life Sciences/Pharmacy/Nursing/Biotech

Job description

Job Summary

We are looking for skilled and motivated professionals in Clinical Data Management (CDM) to join our team. The ideal candidate should have knowledge of clinical trial data management processes, clinical data review, query management, and clinical database activities.

Key Responsibilities

• Perform clinical data management activities for clinical trials.
• Review and validate clinical trial data for accuracy, completeness, and consistency.
• Perform data entry, data review, and discrepancy management.
• Raise, track, and resolve data queries.
• Support database design, testing, validation, and maintenance.
• Perform medical coding and reconciliation activities, as applicable.
• Work on clinical data cleaning and database lock activities.
• Ensure compliance with CDISC standards, SOPs, and regulatory guidelines.
• Coordinate with clinical operations, medical coding, and other project teams.
• Maintain data quality and meet project timelines.

Required Skills

• Knowledge of Clinical Data Management (CDM) processes.
• Understanding of clinical trials and clinical research.
• Knowledge of CRF/eCRF, EDC systems, and query management.
• Familiarity with clinical data review and data validation.
• Knowledge of GCP guidelines and regulatory requirements.
• Good analytical, communication, and problem-solving skills.
• Knowledge of CDISC standards (SDTM/ADaM) is an added advantage.

Preferred Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related field.
• Prior experience in Clinical Data Management or clinical research is preferred

Contact HR

Subashree:[phone] , [phone]