Clinical Database Designer

Job Title: Clinical Database Designer (23 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.

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.
• Strong analytical, documentation, and problem-solving skills.