Clinical Database Designer (Mumbai) at Medpace, Inc.

Navi Mumbai, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

06 Feb, 26

Salary

0.0

Posted On

08 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Database Design, eCRF Development, Edit Check Specifications, Data Validation, Communication Skills, Attention to Detail, Team Collaboration, Reporting Tools, Protocol Review, Database Management

Industry

Pharmaceutical Manufacturing

Description

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). 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 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. 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 What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Responsibilities

The Clinical Database Designer will maintain eCRF and Edit Check Specification standard templates according to CDISC standards and develop eCRF specifications on a study-by-study basis. They will also perform validation of eCRFs and liaise with Data Managers and Sponsors to ensure proper understanding and setup of the EDC database.