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 robust 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:

- 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.

📌 Clinical Database Designer (Hyderabad)
🏢 Inductive Quotient Analytics India
📍 Hyderabad