Clinical Data Management Executive

Why This Role Matters

Clinical Data Management (CDM) is a critical component of clinical research that ensures the accuracy, consistency, and integrity of clinical trial data. Proper data management enables pharmaceutical companies and research organizations to analyze clinical outcomes, evaluate drug safety and efficacy, and support regulatory submissions. The Clinical Data Management Executive role focuses on managing clinical trial data throughout the study lifecycle, including electronic case report form development, data validation, medical coding, and reconciliation activities. Professionals in this role ensure that clinical trial data is collected, reviewed, and maintained according to regulatory standards and Good Clinical Practice guidelines.
By supporting data quality checks, query management, and clinical database activities, CDM professionals play an important role in maintaining reliable clinical data used in regulatory submissions and scientific research. For candidates with backgrounds in pharmacy, life sciences, or clinical research coordination, this role provides valuable exposure to global clinical trial data management processes.

Job Description

Lambda Therapeutic Research is seeking a Clinical Data Management Executive to support clinical trial data management activities at its Ahmedabad location. The selected candidate will be responsible for supporting electronic data capture processes, reviewing clinical data for accuracy, managing data queries, and assisting with clinical data management documentation. The role also involves medical coding activities, data reconciliation, and training related to clinical data management systems.
The position requires collaboration with clinical research teams, data managers, and project stakeholders to ensure that clinical data is processed, validated, and maintained according to study protocols and regulatory requirements.

Key Features of the Role

• Opportunity to work in clinical data management within a global CRO
• Exposure to electronic data capture systems and clinical trial databases
• Involvement in eCRF development and clinical data validation processes
• Participation in query management and data reconciliation activities
• Collaboration with clinical research teams and data management professionals
• Opportunity to contribute to clinical trial documentation and data quality initiatives

Responsibilities

eCRF Development and Testing

• Support development and configuration of electronic Case Report Forms for clinical trials
• Participate in testing of eCRF functionality and ensure data capture aligns with study protocols
• Assist in identifying and resolving system issues during testing phases

Data Validation and Query Management

• Perform data validation checks to ensure clinical trial data accuracy and completeness
• Generate and manage data queries related to discrepancies or missing information
• Work with site teams and clinical staff to resolve data queries within defined timelines

Clinical Data Management Documentation

• Support preparation and maintenance of clinical data management documents
• Assist in developing documents such as Data Management Plans, Data Validation Plans, and electronic CRF completion guidelines
• Ensure documentation is maintained according to regulatory and project requirements

Data Reconciliation and Medical Coding

• Support reconciliation of clinical trial data across different systems
• Perform medical coding activities for clinical data using standardized terminology systems
• Assist in reviewing coded data to ensure accuracy and consistency

Training and System Support

• Provide support and training to project teams regarding data management systems and processes
• Assist in training related to electronic data capture tools and data entry procedures
• Participate in process improvement initiatives within the data management function

Required Qualifications

Educational Requirements

• M.Pharm (Pharmacology or Quality Assurance)
• BDS, BAMS, or BHMS
• M.Sc in Life Sciences or related healthcare fields

Experience and Skills

• Experience working as a Clinical Research Coordinator at the site level for late-phase clinical trials
• Experience with clinical data management processes and data handling activities
• Familiarity with electronic data capture systems and related clinical trial tools
• Knowledge of clinical research guidelines and documentation practices
• Strong attention to detail and analytical abilities
• Ability to manage multiple tasks and maintain accurate documentation

Technical Skills

• Experience with EDC systems used in clinical trials
• Familiarity with systems such as IWRS, ePRO, or similar clinical research tools
• Understanding of clinical database management and query resolution processes
• Basic knowledge of medical coding and clinical data validation activities

Salary Insights

The compensation for this role ranges between ₹3,00,000 and ₹6,00,000 per year depending on experience, qualifications, and relevant technical expertise. Additional benefits may include exposure to global clinical research projects, training opportunities, and career growth within clinical data management and clinical research operations.

Company Overview

Lambda Therapeutic Research is a global full-service Clinical Research Organization headquartered in Ahmedabad, India. The organization provides comprehensive clinical research services to pharmaceutical, biotechnology, and generic drug companies worldwide. With research facilities and operational centers in multiple international locations including the United States, Canada, Spain, the United Kingdom, and Poland, Lambda Therapeutic Research supports global clinical trials and regulatory research initiatives. The organization focuses on delivering high-quality clinical research solutions while ensuring compliance with international regulatory standards and Good Clinical Practice guidelines.

FAQs

Who can apply for this role?
Candidates with qualifications such as M.Pharm, BDS, BAMS, BHMS, or M.Sc in Life Sciences.

What experience is required for this position?
Applicants with site-level experience working as Clinical Research Coordinators in late-phase clinical trials are preferred.

What type of work will the CDM Executive perform?
The role involves clinical data management activities including eCRF development, data validation, query management, medical coding, and data reconciliation.

Which tools are commonly used in this role?
The role involves working with electronic data capture systems and tools such as IWRS, ePRO, and other clinical trial data platforms.

What is the salary range for this position?
The salary typically ranges between ₹3,00,000 and ₹6,00,000 per year depending on experience.

Application Tips

• Highlight experience working as a Clinical Research Coordinator or in clinical trials
• Mention familiarity with EDC systems and clinical data management tools
• Demonstrate knowledge of clinical trial documentation and data validation processes
• Showcase experience in query management and data reconciliation activities
• Emphasize attention to detail and ability to maintain high data quality standards