Associate Data Manager

WOW Softech; Faridabad District; On-site; INR 1,600,000 - 2,200,000; Full time

Job summary

WOW Softech is seeking an experienced Clinical Data Manager in India with 6+ years in Core CDM and 2+ years handling external data (Lab & ECG). Hands-on Medidata Rave EDC experience required to manage studies from start-up to database lock.

You'll draft study documents, oversee data listings, QC, UAT, and ensure compliance with SOPs, GCP, and regulatory requirements while collaborating with cross-functional teams.

Qualifications

• 6+ years of Core Clinical Data Management experience.
• 2+ years of external data handling (Lab & ECG).
• Hands-on Medidata Rave EDC experience.

Responsibilities

• Perform clinical data management activities from start-up to closeout.
• Draft and review study documents (DMP, eCRF guidelines, DRP, database design specs, DVP).
• Data listing review and query management.
• User Acceptance Testing (UAT).
• External data reconciliation (Lab & ECG).
• Prepare study-specific reports.
• Database freeze and lock activities.
• Review vendor data transfer agreements/specifications.
• QC of listings and closed queries.
• Filing and maintenance in eTMF.
• Support study closeout activities and other assigned responsibilities.
• Ensure adherence to SOPs, GCP, and regulatory requirements.
• Collaborate with cross-functional teams.

Skills

CDM

Data reconciliation

Query management

UAT

Documentation

Tools

Medidata Rave EDC

Job description

6 + 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.

• Perform clinical data management activities throughout the study lifecycle, from start‑up to closeout.
• Drafting and review of study specific documents (DMP, eCRF completion guidelines, DRP, database design specifications, DVP.
• 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/ drafting 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.
• Collaborate with cross‑functional teams.
• Perform additional duties and responsibilities as assigned.