Analyst Clinical Data Management
Syngene International
- Bangalore, Karnataka
- Permanent
- Full-time
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company's integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene' s quality standards at all times
- Hold self and their teams accountable for the achievement of safety goals
- Govern and Review safety metrics from time to time
- Design and develop clinical study databases within EDC systems as per protocol and CRF specifications.
- Configure eCRFs, visit structures, edit checks, derivations, and study workflows.
- Perform database validation and execute UAT to ensure system functionality and compliance.
- Create and maintain edit check specifications and test scripts.
- Support data cleaning activities by troubleshooting and resolving system-related queries.
- Implement mid-study updates, amendments, and change control processes.
- Ensure compliance with GCP, CDISC standards, and 21 CFR Part 11 requirements.
- Maintain study documentation including build documents, validation records, and audit trails.
- Collaborate with Data Management, Biostatistics, Clinical Operations, and Sponsors for study setup and maintenance.
- Support database lock activities and assist in system integrations (e.g., ePRO, IWRS, laboratory data).
- Demonstrates accountability and ownership of assigned studies.
- Proactively communicates risks and challenges to stakeholders.
- Works collaboratively within cross-functional teams.
- Shows willingness to learn and adapt to new systems and processes.
- Contributes positively to team performance and timelines.
- Excellence
- Integrity
- Professionalism
- Experience
- Hands-on experience in EDC database programming within clinical trials.
- Experience working on Phase I-IV studies preferred.
- Exposure to database build, testing, and maintenance activities.
- Demonstrated Capability
- Ability to interpret study protocols and translate them into database specifications.
- Experience in creating edit checks and validation rules.
- Capability to manage multiple tasks within defined timelines.
- Basic understanding of CDISC standards and regulatory compliance (GCP).
- Education
- Bachelor's/master's degree in: Computer Science/Information Technology
- Training in GCP, CDISC, or clinical data management is an added advantage
- Proficiency in EDC platforms (e.g., Medidata Rave, Inform, Veeva, Clinion or equivalent).
- Strong analytical and problem-solving skills.
- Good written and verbal communication skills.
- Attention to detail and commitment to data quality.
- Ability to work in a deadline-driven environment.
- Bachelor's/master's degree in: Computer Science/Information Technology
- Training in GCP, CDISC, or clinical data management is an added advantage
- Certification in Clinical Data Management or EDC systems (preferred).