Clinical Database Designer (Mumbai)

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.

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 Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• • Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• • Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
  • Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• • Office based environment with on-site mentors
  • Defined career paths with clear advancement opportunities
  • Industry renowned onboarding and training programs designed to accelerate professional development
  • Ongoing training and continuous learning opportunities throughout your career
  • An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• • Competitive compensation programs that recognize and reward performance
  • Comprehensive health, wellness, retirement, and PTO benefits
  • Office based culture with occasional WFH that provides flexibility for eligible positions after training
  • Company-sponsored social events

Please note benefits may vary based on country.

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.