Medpace is hiring a Clinical Database Designer for its Biometrics team in Navi Mumbai, India. This is a full-time, office-based opportunity within the Data Management function.
The role involves designing and maintaining Electronic Case Report Forms (eCRFs), developing Edit Check Specifications, validating EDC databases, and collaborating with Data Managers, Clinical Database Programmers, and Sponsors throughout the clinical study lifecycle.
Candidates with experience in EDC database specifications and User Acceptance Testing (UAT) can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Medpace |
| Job Role | Clinical Database Designer |
| Job ID | 12325 |
| Location | Navi Mumbai, India |
| Department | Data Management |
| Job Type | Full-Time |
| Work Mode | Office-Based |
| Team | Biometrics |
| Experience | At least 1 year |
| Qualification | Bachelor’s / Advanced Degree |
| Industry | Clinical Research / CRO |
Position
Clinical Database Designer
The selected candidate will be responsible for developing and maintaining study-specific eCRF and Edit Check Specifications, validating EDC databases, and ensuring clinical data collection requirements align with study protocols and CDISC standards.
Key Responsibilities
- Maintain standard eCRF and Edit Check Specification templates according to CDISC standards.
- Develop and maintain study-specific eCRF specifications by reviewing clinical study protocols and customizing library eCRFs.
- Manage eCRF specifications from database build through database lock, including change requests.
- Develop and maintain Edit Check Specifications to ensure data completeness, logical consistency, and compliance with study assessment schedules.
- Perform validation of eCRFs and edit checks according to specifications, ensuring all possible data-entry scenarios are tested and documented.
- Provide clear and reliable feedback to Clinical Data Programmers.
- Coordinate with Data Managers and Sponsors to ensure eCRFs are understood and EDC databases meet sponsor expectations.
- Collaborate with Clinical Database Programmers to ensure specifications are clearly defined and technically feasible.
- Design and develop customized project-level reports using EDC reporting tools such as Business Objects and JReview.
- Lead internal and external eCRF specification review meetings.
- Explain technical design decisions and discuss alternative solutions with Sponsors when required.
Eligibility and Qualifications
Candidates must meet the following requirements:
- Bachelor’s degree or advanced degree in Life Sciences, Computer Science, or an equivalent qualification.
- At least one year of experience in building specifications and/or performing User Acceptance Testing (UAT) for EDC databases.
- Excellent verbal and written communication skills.
- Meticulous attention to detail.
Required Skills and Technical Knowledge
- Electronic Data Capture (EDC) database specifications
- Electronic Case Report Forms (eCRF)
- Edit Check Specifications
- CDISC standards
- User Acceptance Testing (UAT)
- Clinical study protocol review
- EDC database validation
- Change Request management
- Clinical Data Management coordination
- Business Objects
- JReview
- Sponsor communication and stakeholder management
