Data Coordinator

WOW Softech; Faridabad District; On-site; INR 700,000 - 900,000; Full time

Job summary

WOW Softech in India is seeking a Clinical Data Management professional with at least 3 years of core CDM, including 2+ years external data handling (Lab & ECG). You will manage activities from start-up to database lock using Medidata Rave EDC.

Responsibilities include data listing review, UAT, QA of listings, eTMF filing, vendor data transfer reviews, and ensuring SOP/GCP compliance across global trials. Previous exposure to multiple external data vendors is a plus.

Qualifications

• At least 3 years of Core CDM experience.
• 2+ years external data handling and reconciliation (Lab & ECG).
• Hands-on experience with Medidata Rave EDC.
• Experience from start-up through database lock.
• Experience in global clinical trials is a plus.

Responsibilities

• 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 of listings and closed queries.
• Filing and maintenance of study documentation in eTMF.
• Support study closeout activities and other assigned responsibilities.
• Ensure adherence to SOPs, GCP guidelines, and regulatory requirements.
• Perform additional duties and responsibilities as assigned.

Skills

Clinical Data Management

Medidata Rave

Lab data reconciliation

ECG data reconciliation

Data listing review

UAT

Database lock

Vendor data transfer

Quality control

eTMF filing

Study start-up

GCP compliance

Regulatory knowledge

Education

B. Pharm/M. Pharm/Life Sciences

Postgraduate

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.

Qualification: B. Pharm/M. Pharm/Life Sciences Graduate, Postgraduate

Additional Skills:

• Experience working with global clinical trials.
• Knowledge of clinical data management SOPs and regulatory requirements.
• Exposure to multiple external data vendors and reconciliation processes.