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About the role
Job Title: Clinical Database Designer (2-3 Years Experience) About Inductive Quotient Analytics Pvt Ltd. Inductive Quotient Analytics is a rapid-growing CLIN Tech CRO that was founded with a singular commitment to help life sciences - pharmaceutical, biotech, nutraceutical and healthcare companies simplify, accelerate and scale their clinical trials to reduce time-to-market through streamlined delivery of novel treatments and medical innovations to patients. We offer end-to-end biometrics services Biostatistics, Clinical Data Management, Statistical Programming and Clinical Programming, along with Real World Evidence and HEOR. We also have a strong medical affairs team that takes care of Medical Writing and Medical Coding. Our product engineering arm has built an AI-based homegrown solution to accelerate clinical trials. It enables global pharma and biotechnology companies to swiftly conduct clinical trials with high efficiency and achieve faster approvals. Visit our website: www.inductivequotient.com Roles & Responsibilities: - Design and develop Electronic Case Report Forms (eCRFs) based on clinical study protocols, CRF specifications, and study requirements using Medidata Rave, Veeva Vault CDMS, and other EDC platforms. - Provide technical inputs and recommendations during the database setup and development phase of clinical studies. - Configure and manage in-house and third-party integrations including IXRS/IWRS and external vendor integrations. - Perform programming activities including: - Dynamics configuration - Derivations - Edit checks programming - Data validation rules - Perform Lab Module setup and configuration within EDC systems. - Conduct peer review, testing, and validation of database programming activities and eCRF builds. - Collaborate with Sponsors, Clinical Data Managers, and study teams for eCRF review, feedback incorporation, and database optimization. - Ensure compliance with best practices, SOPs, standards, and clinical data management guidelines. - Demonstrate strong understanding of Clinical Data Management (CDM) processes, 21 CFR Part 11, ICH-GCP guidelines, and regulatory requirements. - Ensure all programming activities, documentation, and data acquisition processes are high quality, audit-ready, and compliant with regulatory standards. - Perform data extraction activities and support CDASH standards implementation. - Manage end-to-end activities including: - Database design specification - eCRF development - Programming - Testing - Validation - Dataset extraction - Analyze complex technical issues, provide recommendations, and implement effective solutions. - Maintain knowledge of regulatory requirements related to electronic submissions and clinical trial data standards. - Support audit readiness by maintaining proper documentation and ensuring adherence to data acquisition procedures. - Manage multiple clinical studies/projects simultaneously while ensuring timely delivery and meeting project milestones. Required Skills & Experience: - 23 years of experience in EDC Programming / Clinical Database Design. - Hands-on experience with Medidata Rave, Veeva Vault CDMS, or other EDC platforms. - Strong knowledge of: - eCRF development - Edit checks - Dynamics - Derivations - Lab Module configuration - Data extraction - Validation processes - Good understanding of Clinical Data Management workflows and clinical trial lifecycle. - Knowledge of CDASH standards, 21 CFR Part 11, ICH-GCP, and regulatory compliance requirements. - Experience in database testing, peer review, and validation activities. - Ability to work with cross-functional teams including Sponsors, Data Managers, and Clinical teams. - Solid analytical, documentation, and problem-solving skills. .