Senior Clinical Database Designer
ROLE OVERVIEW
IQVIA is the world's largest clinical research organisation, and its Kochi delivery centre supports hundreds of global trials across oncology, cardiology, vaccines and rare disease. The Senior Clinical Database Designer owns the technical backbone of a study's data capture: interpreting the protocol, designing the electronic case report form (eCRF), writing edit specifications and configuring the InForm EDC environment so that clean, submission-ready data reaches sponsors on time. Because every downstream deliverable — statistical analysis, regulatory submission, safety reporting — depends on the database being built correctly the first time, this is a high-visibility, high-accountability position. It suits a detail-obsessed clinical data professional who wants to deepen EDC and technical design expertise inside a global CRO, with structured exposure to ICH-GCP, CDISC-adjacent standards and sponsor-facing collaboration.
ROLE DEFINITION & RESPONSIBILITIES
- •Interpret clinical study protocols and translate endpoints, visit schedules and assessments into a complete eCRF structure within the InForm EDC platform.
- •Author and maintain the Edit Specification Document, defining validation rules, discrepancy logic and data-cleaning checks per field.
- •Generate specifications for EDC build components including Rights and Roles, system settings, home page configuration and LLRR data collection.
- •Complete the Study Authorization Form and Trial Capacity Request Form, configuring entry and update access in line with the Rights and Roles document.
- •Lead the Internal Edit Specification Review Meeting and Online Screen Review Meeting, presenting design comments and resolving reviewer feedback.
- •Attend Pre-Design, Unblinded Data Review and Internal Design Review meetings, documenting agreed decisions and follow-up actions.
- •Track build timelines against the Data Management Project Plan and escalate risks, potential delays and quality issues to the Data Team Lead.
- •Keep project-specific training records current and stay compliant with applicable Standard Operating Procedures.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Science, Computer Science, Information Technology or B.Tech (life-sciences background such as B.Pharm/BSc preferred).
- 5+ years of total professional experience, including 0-2 years of dedicated clinical database design or EDC technical build work.
- Hands-on familiarity with InForm EDC or a comparable platform such as Medidata Rave or Veeva Vault CDMS.
- Working knowledge of ICH-GCP, 21 CFR Part 11 and end-to-end clinical data management processes.
- Proven ability to read a clinical trial protocol and convert it into database and edit-check specifications.
- Strong documentation discipline with meticulous attention to detail and version control.
- Availability for a full-time on-site role at IQVIA's Kochi delivery centre.
PREFERRED QUALIFICATIONS
- •Medidata Rave or Veeva Vault CDMS
- •CDISC SDTM / CDASH Awareness
- •LLRR (Local Lab Reference Range) Setup
- •Basic SQL or Data Query Skills
- •Oncology, Vaccine or Rare Disease Trial Exposure
REQUIRED VERIFIED SKILLS
COMPENSATION & REWARDS
ORGANIZATION CONTEXT & CULTURE
IQVIA is a leading global provider of advanced analytics, technology solutions, and contract research services (CRO) to the life sciences industry. The company helps pharmaceutical, biotech, and medical device clients accelerate the development and commercialization of new medical treatments through its extensive data, technology, and human expertise. Their offerings span from clinical trial design and execution to real-world evidence and commercial effectiveness.
EXPECTED CAREER ROADMAP
APPLICATION ADVISORY
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