Technical Officer – Clinical Data Coordinator
Location: Ahmedabad, India
Company: Lambda Therapeutic Research Ltd.
Industry: Clinical Research / Clinical Data Management / Drug Development
Employment Type: Full-Time
Experience Required: Relevant clinical research and data management experience (site-level experience preferred)
Compensation: INR 3,00,000 – 6,00,000 per annum
Organization Overview
Lambda Therapeutic Research is a global full-service Contract Research Organization (CRO) headquartered in Ahmedabad, India. The organization provides comprehensive clinical research and drug development services to global pharmaceutical, biotechnology, and generic drug companies. With operational facilities across India, the United States, Canada, Spain, the United Kingdom, and Poland, Lambda supports end-to-end clinical research, regulatory compliance, and data management solutions for global healthcare innovation.
Job Overview
The Technical Officer – Clinical Data Coordinator is responsible for supporting clinical data management activities, electronic data capture (EDC) processes, and medical coding in clinical trials. The role involves eCRF development, data validation, query management, and clinical data documentation to ensure data quality, accuracy, and regulatory compliance throughout the clinical research lifecycle. This position is ideal for professionals with experience in clinical research coordination and clinical data management.
Key Responsibilities
Clinical Data Management Operations
Develop and test electronic Case Report Forms (eCRFs) for clinical trials.
Perform clinical data validation and manage data queries to ensure data accuracy and completeness.
Support clinical data management documentation, including Data Management Plans (DMP), Data Validation Plans (DVP), and electronic Case Completion Guidelines (eCCG).
Conduct data reconciliation activities to ensure consistency across clinical data sources.
Medical Coding and Data Quality
Perform medical coding activities using standard coding dictionaries and guidelines.
Ensure compliance with clinical data management standards, regulatory requirements, and quality processes.
Monitor data integrity and support data cleaning activities.
System and Process Support
Work with Electronic Data Capture (EDC) systems and related clinical technologies such as Interactive Web Response Systems (IWRS) and electronic Patient-Reported Outcomes (ePRO).
Provide training and support related to clinical data management processes and systems.
Collaborate with cross-functional teams to maintain high standards of data quality and regulatory compliance.
Documentation and Compliance
Maintain accurate clinical data management documentation and project records.
Ensure adherence to global regulatory standards, Good Clinical Practice (GCP), and organizational procedures.
Support continuous improvement initiatives within clinical data management operations.
Educational Qualifications
M.Pharm (Pharmacology or Quality Assurance), or
BDS, BAMS, BHMS, or
M.Sc. in Life Sciences or related discipline.
Experience Requirements
Site-level experience as a Clinical Research Coordinator, particularly in late-phase clinical trials.
Hands-on experience with Electronic Data Capture (EDC) systems and related tools such as IWRS and ePRO.
Experience in clinical data management activities, including data validation and reconciliation.
Required Skills and Competencies
Strong understanding of clinical trial processes and data management principles.
Knowledge of Good Clinical Practice (GCP) and regulatory requirements.
Attention to detail with strong analytical and problem-solving skills.
Good communication and documentation skills.
Ability to work collaboratively in a cross-functional research environment.
Career Growth Opportunities
Exposure to global clinical trial data management practices and regulatory standards.
Opportunity to work in a multinational CRO environment.
Professional development in clinical data management, clinical research operations, and regulatory compliance.
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