Roles & Responsibilities
• Manage clinical trial databases ensuring accurate and high-quality data flow
• Perform data review, cleaning, and validation activities
• Design, develop, and review eCase Report Forms (eCRFs)
• Ensure compliance with ICH-GCP, ICH, EU, and FDA regulatory guidelines
• Support study start-up, maintenance, and close-out activities
• Collaborate with cross-functional teams to maintain data integrity
• Contribute to audit readiness and regulatory inspection support
• Maintain proper documentation throughout the clinical trial lifecycle
Qualification
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related scientific discipline
Experience
• Minimum 1 year of experience as a Clinical Data Manager or Data Management Associate
• Equivalent combination of education, training, and experience may be considered
Skills
• Strong knowledge of clinical data management processes
• Understanding of end-to-end clinical trial lifecycle
• Hands-on experience with clinical trial databases and CDMS tools
• Sound knowledge of ICH-GCP and global regulatory requirements
• Excellent documentation, communication, and coordination skills
• Fluent in English (written and spoken)
• Ability to work collaboratively in cross-functional teams
About the Organisation
Excelya is a fast-growing, global Contract Research Organization (CRO) known for its people-centric culture and strong presence in Europe and India. The company supports global clinical trials in regulatory-compliant environments, offering professionals long-term career growth, exposure to international studies, hybrid work flexibility, and continuous learning opportunities within a collaborative and inclusive workplace.
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