Clinical Database Designer (Mumbai)

Medpace Clinical Research India; Navi Mumbai; On-site; INR 600,000 - 800,000; Full time

Benefits offered by this job

Flexible work environment

Competitive compensation and benefits package

Competitive PTO packages

Structured career paths with opportunities for professional growth

Company-sponsored employee appreciation events

Employee health and wellness initiatives

Job summary

Medpace Clinical Research India is looking for a full-time Clinical Database Designer to join the Biometrics team. This role involves maintaining eCRF standards, developing specifications, and performing validations for clinical databases. Candidates should have a relevant degree and experience in EDC databases.

The position offers a flexible work environment and opportunities for growth, along with a competitive compensation package and benefits.

Qualifications

• At least one year experience building specifications and performing UAT for EDC databases.

Responsibilities

• Maintain eCRF and Edit Check Specification standard templates according to CDISC standards.
• Develop and maintain eCRF specifications on a study-by-study basis.
• Perform validation of both the eCRF and the edits per the specifications.
• Liaise and educate the Data Manager and Sponsor to ensure eCRFs are well understood.
• Design and develop customized project-level reports within the EDC systems.

Skills

Excellent verbal and written communication skills

Meticulous attention to detail

Education

Bachelor’s degree/Advanced degree in Life Sciences or Computer Science or equivalent

Job description

Title

Our global activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Database Designer to join our Biometrics team. This position will work in a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Responsibilities

• Maintain eCRF and Edit Check Specification standard templates according to CDISC standards for data collection and data submission;
• Develop and maintain eCRF specifications on a study‑by‑study basis (e.g., reviewing protocol and customize library eCRFs to apply for the study) from database build through database lock (including Change Requests);
• Develop and maintain Edit Check Specifications from database build through database lock (including Change Requests) to ensure that all data collected are present, logical, and per expected protocol assessment schedule and completion guidelines;
• Perform validation of both the eCRF and the edits per the specifications ensuring that all possible entry scenarios are tested and documented. Accountable for providing reliable and concise feedback to clinical data programmer;
• Liaise and educate the Data Manager and Sponsor to ensure that eCRFs are well understood, and the EDC database is set up per Sponsor expectations (e.g., attend ongoing meetings with the Sponsor during setup of study);
• Liaise with Clinical Db Programmer to ensure that eCRF and Edit Check Specifications are clearly defined and can be accomplished in the referenced system;
• Design and develop customized project‑level reports that are useful to the team via the reporting tools within the EDC systems (e.g., Business Objects, JReview);
• Lead eCRF specification review meetings with internal project team to discuss eCRF specifications; and
• Lead eCRF specification review meetings with external project team to discuss eCRF specifications and speak knowledgeably about decisions made and technical design options if Sponsor does not agree with current design.

Qualifications

• Bachelor’s degree/Advanced degree in Life Sciences or Computer Science or equivalent;
• At least one year experience building specifications and/or performing UAT for EDC databases
• Excellent verbal and written communication skills; and
• Meticulous attention to detail.

Medpace Perks

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company‑sponsored employee appreciation events
• Employee health and wellness initiatives

Awards

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility