Data Management Associate
Location: Hyderabad, India
Work Mode: On-Site
Department: Clinical Development
Job Summary
We are seeking a detail-oriented Data Management Associate to support clinical trial data management activities throughout the study lifecycle. The successful candidate will contribute to data collection, validation, cleaning, reconciliation, and database management processes to ensure the delivery of high-quality, accurate, and compliant clinical data. This role offers an excellent opportunity to gain end-to-end exposure to clinical data management within global clinical research programs.
Experience Required
2–4 years of experience in Clinical Data Management or Clinical Research.
Minimum 1 year of experience supporting clinical trials within a pharmaceutical, biotechnology, or CRO environment.
Experience working on global clinical studies is preferred.
Educational Qualification
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Nursing, or a related discipline.
Key Responsibilities
Support clinical data management activities throughout the study lifecycle, including study startup, conduct, database lock, and closeout.
Assist with database build activities, edit check testing, coding setup, laboratory data integration, and data validation processes.
Perform routine data cleaning, query generation, query resolution tracking, and reconciliation activities.
Monitor clinical data quality and identify data inconsistencies, trends, and potential issues requiring escalation.
Support database lock preparation activities and ensure readiness for study milestones.
Prepare, maintain, and review study documentation, including testing scripts, reconciliation trackers, data review reports, and lock readiness materials.
Collaborate with cross-functional teams including Clinical Operations, Biostatistics, Medical Monitoring, Programming, and Clinical Data Management.
Utilize Electronic Data Capture (EDC) systems and clinical data management platforms effectively.
Ensure compliance with GCP, regulatory requirements, SOPs, and data management standards.
Contribute to process improvements and support efficient clinical trial data delivery.
Required Skills
Knowledge of Clinical Data Management principles and clinical trial processes.
Experience with EDC platforms such as Medidata Rave, Veeva Vault, or similar systems.
Strong understanding of data cleaning, query management, and reconciliation activities.
Familiarity with clinical trial documentation and database lock procedures.
Excellent analytical and problem-solving skills.
Strong attention to detail and data quality focus.
Effective communication and stakeholder collaboration abilities.
Ability to manage multiple priorities in a fast-paced clinical research environment.
Preferred Skills
Experience supporting global clinical trials.
Understanding of CDISC standards and clinical data workflows.
Knowledge of regulatory requirements, GCP guidelines, and industry best practices.
Exposure to coding dictionaries such as MedDRA and WHO Drug is advantageous.
Career Opportunities
This role provides a strong foundation for career progression into Clinical Data Management, Clinical Operations, Data Standards, Clinical Programming, Biostatistics Support, and Clinical Trial Management functions within the pharmaceutical and biotechnology industries.
Uttar Pradesh :
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Warsaw |