Data Management Associate (clinical operations)

Auriga Research; Gurugram District; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Auriga Research is seeking a Data Management Lead to oversee EDC/eCRF review, data quality checks, and vendor coordination during study milestones. The role requires 4+ years in data management within CROs or sponsor teams, and hands-on experience with major EDC platforms.

You will resolve site data entry queries, support database go-live readiness, and prepare data handoffs to statisticians. Strong collaboration with sites, CRAs, and Biostatisticians is essential, as is ensuring data integrity

Qualifications

• B.Pharm / M.Sc / B.Tech with 4+ years data management experience in CRO/Sponsor.
• Hands-on experience with at least one major EDC platform.
• Experience coordinating with site staff to resolve data entry queries and data quality issues.
• Experience extracting datasets from an EDC system and preparing handoff to a statistician.

Responsibilities

• Review vendor-built EDC/eCRF builds at milestones to ensure protocol alignment.
• Sign off on database go-live readiness after testing.
• Regularly review site data entry activity to identify inconsistencies and errors.
• Provide day-to-day assistance on data entry queries and EDC navigation.
• Manage data query workflows with sites and CRAs for timely resolution.
• Conduct routine data quality checks and flag issues to Data Management Lead and vendor.
• Support database lock activities including final data cleaning and reconciliation ahead of extraction.
• Prepare study data for handoff and share datasets with the Biostatistician in required format.

Skills

Data management experience

EDC platform experience

Query resolution

Education

B.Pharm / M.Sc / B.Tech

Job description

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