Data Management Associate (clinical operations)

Role & responsibilities

Review the EDC/eCRF build developed by the third-party vendor at each development milestone

(build, UAT, and pre-go-live testing) to confirm alignment with protocol and Data Management

Plan requirements

• Sign off on database go-live readiness following successful review and testing of the vendor-built

EDC

• Conduct regular, ongoing review of site data entry activity during the study conduct phase to

identify inconsistencies, missing data, and entry errors

• Provide day-to-day assistance to site staff on data entry queries, EDC navigation issues, and data

clarification requests

• Manage data query workflows with sites and CRAs, ensuring timely resolution and clear

documentation

• Conduct routine data quality checks throughout the study conduct phase, flagging issues to the

Data Management Lead and vendor as needed

• Support database lock activities, including final data cleaning and reconciliation ahead of

extraction

• Extract study data from the EDC system at defined milestones and at study completion, and

prepare it for handoff

• Share extracted datasets with the Biostatistician in the required format, resolving any structural

queries during handoff

Preferred candidate profile

B.Pharm / M.Sc / B.Tech with 4+ years of data management experience in a CRO/Sponsor

• Hands-on experience working within at least one major EDC platform

• Experience coordinating directly with site staff to resolve data entry queries and data quality

issues

• Experience extracting datasets from an EDC system and preparing them for handoff to a

statistician