Clinical Data Analyst: Data Integrity & EDC Specialist

WhiteCap Search

Bridgewater (MA)

On-site

USD 80,000 - 110,000

Full time

3 days ago
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Job summary

WhiteCap Search is seeking a dedicated Data Management professional to support assigned DM studies in Bridgewater, NJ, ensuring GCP compliance and data quality.

Responsibilities include updating DMPs and CRF guidelines, reviewing EDC discrepancies, running study metrics, and reconciling external data to the clinical database. Strong collaboration and attention to detail are required.

2+ years in biotech/pharma/CRO data management with Associates degree or higher preferred.

Qualifications

  • Hands-on experience with Electronic Data Capture systems (Medidata Rave desired).
  • Excellent communication skills (verbal and written).
  • Experienced working in a cross-functional team environment.
  • Strong organizational skills.

Responsibilities

  • Facilitate updating Data Management Documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, and CRF Completion Guidelines per Lead DM expectations.
  • Verify external vendor test data per specifications document.
  • Run and review outputs and database study metrics.
  • Participate in data reviews.
  • Review discrepancies in the Electronic Data Capture (EDC) system, monitor/facilitate resolution, and close out or re-query per study guidelines. Note and communicate trends to clinical trial manager(s) for follow-up.
  • Reconcile external data to the clinical study database and perform Serious Adverse Event reconciliation.
  • Ensure Data Management procedures and processes are adhered to in a consistent manner.
  • Provide high-quality services through efficient and compliant processes.

Skills

EDC systems
Communication skills
Cross-functional team
Organizational skills

Education

Associates Degree or higher

Tools

Medidata Rave

Job description

WhiteCap Search is seeking a dedicated Data Management professional to support assigned DM studies in Bridgewater, NJ, ensuring GCP compliance and data quality.

Responsibilities include updating DMPs and CRF guidelines, reviewing EDC discrepancies, running study metrics, and reconciling external data to the clinical database. Strong collaboration and attention to detail are required.

2+ years in biotech/pharma/CRO data management with Associates degree or higher preferred.

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