Clinical Data Specialist
Location: Bangalore, India
Employment Type: Full-Time
Department: Clinical Data Management
Experience Required: 5–8 Years
Position Overview
We are seeking an experienced Clinical Data Specialist to support clinical research and data management activities by ensuring the collection, validation, processing, and reporting of high-quality clinical data. The successful candidate will play a key role in managing Electronic Data Capture (EDC) systems, maintaining data integrity, supporting regulatory compliance, and collaborating with cross-functional teams to facilitate clinical study execution and analysis.
This position is ideal for professionals with strong experience in Clinical Data Management (CDM), EDC platforms, database programming, and clinical trial data processing within the pharmaceutical, biotechnology, or medical device industries.
Key Responsibilities
Clinical Data Management
Configure, maintain, and support Electronic Data Capture (EDC) systems and clinical databases.
Execute technical setup and implementation of clinical data management solutions for clinical studies.
Ensure accurate collection, validation, processing, and maintenance of clinical trial data.
Monitor data quality, consistency, and completeness throughout the study lifecycle.
Perform data cleaning activities, query management, and discrepancy resolution.
Data Quality & Compliance
Ensure compliance with applicable regulatory requirements, GCP guidelines, company SOPs, and industry standards.
Review and evaluate clinical data for accuracy, integrity, and completeness.
Identify, investigate, and resolve data discrepancies, anomalies, and quality issues.
Support audit readiness and inspection preparedness activities.
Documentation & Reporting
Develop, maintain, and update data management documentation, including:
Standard Operating Procedures (SOPs)
Work Instructions
Data Management Plans (DMPs)
Validation Documentation
Prepare data summaries, listings, tables, and graphical reports for clinical study teams.
Support clinical study reporting and data review activities.
Cross-Functional Collaboration
Work closely with Clinical Operations, Biostatistics, Statistical Programming, Regulatory Affairs, and Medical Writing teams.
Facilitate data transfers and integration activities across systems and stakeholders.
Support study teams by providing data management expertise and recommendations.
Participate in study meetings and contribute to project planning discussions.
Technical Support & Process Improvement
Troubleshoot technical issues related to clinical databases and EDC systems.
Escalate complex technical challenges to appropriate stakeholders.
Recommend process improvements to enhance data quality, efficiency, and compliance.
Mentor junior team members and share best practices in clinical data management.
Required Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, Healthcare, or related discipline.
Experience
5–8 years of experience in Clinical Data Management within the Pharmaceutical, Biotechnology, CRO, or Medical Device industry.
Hands-on experience with clinical database setup, maintenance, and data processing.
Experience supporting clinical trials across multiple phases.
Certifications
CCDM (Certified Clinical Data Manager) or equivalent certification is preferred.
Preferred Technical Skills
Clinical Data Management Systems
Medidata Rave
Greenlight Guru
Electronic Data Capture (EDC) Platforms
Clinical Database Management Systems (CDMS)
Core Competencies
Clinical Data Management
Clinical Trial Data Processing
Data Validation & Query Management
Regulatory Compliance
Data Quality Assurance
Data Harmonization
Documentation & Reporting
Troubleshooting & Root Cause Analysis
Statistical Methods & Data Interpretation
Business Intelligence Tools
Preferred Industry Experience
Pharmaceutical Industry
Biotechnology Industry
Medical Device (MedTech) Industry
Contract Research Organizations (CROs)
Key Skills
Clinical Database Programming
Medidata Database Configuration
EDC System Administration
Clinical Data Review
Data Integrity & Compliance
Study Data Management
Cross-Functional Collaboration
Problem Solving & Analytical Thinking
Communication & Stakeholder Management
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