Job Title: Clinical Data Management (CDM) QA Auditor
Location: Bangalore, Karnataka, India
Employment Type: Full-Time, Permanent
Department: Clinical Data Management / Quality Assurance
About Syngene
Syngene International Ltd. is a global innovation-led contract research, development, and manufacturing organization (CRDMO), providing integrated scientific services from early discovery to commercial supply. Our expertise spans pharmaceuticals, biotechnology, and clinical research, delivering high-quality solutions that meet ICH-GCP and global regulatory standards.
At Syngene, safety, compliance, and scientific excellence form the foundation of our operations. Our multidisciplinary teams collaborate to accelerate drug development and ensure the highest standards in clinical research.
Job Purpose
The CDM QA Auditor is responsible for auditing and reviewing clinical data management activities across BA/BE studies and Phase I–IV clinical trials. This role ensures adherence to GCP, study protocols, SOPs, and regulatory requirements, identifies areas for improvement, and strengthens data quality and compliance within Syngene’s clinical development operations.
Key Responsibilities
Conduct QA audits and reviews for clinical data management (CDM) activities, including BA/BE studies and Phase I–IV clinical trials.
Verify compliance with ICH-GCP (R2), study protocols, data management plans (DMPs), and regulatory requirements.
Perform CRF review, database annotations, and EDC study setup audits to ensure protocol compliance.
Review study-specific CDISC standards and other data standards compliance.
Collect, analyze, and report quality metrics related to CDM functions.
Plan and execute vendor/sub-contractor audits, both onsite and remote, as required.
Collaborate with CDM operations for lessons-learned sessions, risk mitigation, and process improvements.
Lead or co-conduct internal and client audits, ensuring high-quality deliverables and timely CAPA implementation.
Facilitate regulatory inspections and sponsor audits for clinical data management operations.
Maintain QA documentation, SOPs, and quality records to support audit readiness.
Provide training and guidance to project teams on GCP compliance, QA procedures, and data integrity standards.
Support cross-functional initiatives to strengthen the GxP quality system and continuous improvement.
Educational Qualifications & Experience
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field.
5–8 years of experience in clinical data management and quality assurance within CRO, pharmaceutical, or biotech environments.
Proven experience in auditing CDM activities, vendor oversight, and regulatory compliance.
Strong knowledge of ICH-GCP, clinical trial protocols, SOPs, and CDISC standards.
Familiarity with EDC systems (e.g., Medidata Rave), QA tools, and data management platforms.
Technical & Functional Skills
Expertise in audit planning, execution, and reporting.
Strong analytical, organizational, and problem-solving skills.
Ability to mentor and guide teams on data quality and regulatory compliance.
Excellent verbal and written communication skills for collaboration with internal teams, clients, and regulatory bodies.
Proactive approach to process improvement and compliance monitoring.
Behavioral Competencies
Integrity, accountability, and attention to detail.
Team player with ability to work in cross-functional and global teams.
Ability to prioritize tasks, meet deadlines, and adapt to dynamic environments.
Why Join Syngene?
Work with a globally recognized CRDMO driving innovation in drug discovery and development.
Contribute to high-impact clinical data management and QA initiatives.
Opportunities for professional growth, cross-functional exposure, and global collaboration.
Be part of a culture that emphasizes scientific excellence, compliance, and continuous learning.
Equal Opportunity Employer
Syngene is committed to providing equal employment opportunities to all candidates, regardless of age, race, gender, disability, religion, sexual orientation, or other legally protected characteristics. Reasonable accommodations are provided for qualified individuals with disabilities.
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