Associate Data Coordinator/Data Coordinator

WOW Softech

Faridabad District

On-site

INR 600,000 - 900,000

Full time

11 days ago

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Benefits offered by this job

Restaurant d'entreprise

Job summary

WOW Softech is seeking a Clinical Data Manager with at least 3 years of Core CDM experience, including 2+ years handling external data (Lab & ECG) and overseeing studies from start‑up to database lock, with hands‑on Medidata Rave EDC.

Responsibilities include data listing review, query management, UAT, external data reconciliation, study reports, database freeze/lock, vendor data transfer reviews, QC, eTMF filing, and study closeout support, while ensuring SOPs, GCP, and regulatory compliance

Qualifications

  • 3+ years Core Clinical Data Management experience
  • 2+ years external data handling (Lab & ECG) experience
  • Hands-on Medidata Rave EDC experience
  • End‑to‑end study oversight from start‑up to database lock

Responsibilities

  • Data listing review and query management
  • UAT
  • External data reconciliation (Lab & ECG)
  • Preparation of study-specific reports
  • Database freeze and lock activities
  • Review of vendor data transfer agreements/specifications
  • QC of listings and closed queries
  • Filing of study documentation in eTMF
  • Support study closeout activities
  • Adherence to SOPs, GCP, and regulatory requirements

Skills

CDM
Medidata Rave
Data reconciliation
Database lock
UAT testing

Tools

eTMF software

Job description

At least 3 years of Core Clinical Data Management (CDM) experience, including 2+ years of external data handling and reconciliation (Lab & ECG). The ideal candidate should have hands‑on experience with Medidata Rave EDC and be experienced in managing study activities from start‑up through database lock.

  • Data listing review and query management
  • User Acceptance Testing (UAT)
  • External data reconciliation (Lab & ECG)
  • Preparation of study‑specific reports
  • Database freeze and lock activities
  • Review of vendor data transfer agreements/specifications
  • Quality control (QC) of listings and closed queries
  • Filing and maintenance of study documentation in eTMF
  • Support study closeout activities and other assigned responsibilities
  • Ensure adherence to applicable SOPs, GCP guidelines, and regulatory requirements.
  • Perform additional duties and responsibilities as assigned.

DM in Whatsapp - +918116806787(Aaryan Pradhan)

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