Clinical Database Designer

Job Title:

Clinical Database Designer (2–3 Years Experience)
About Inductive Quotient Analytics Pvt Ltd.
Inductive Quotient Analytics is a fast-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.
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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:

2–3 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.
Strong analytical, documentation, and problem-solving skills.