Clinical Data Manager

1 day ago

Menlo Park, California, United States Clinvia LLC Full time

Job Summary

Clinvia LLC is seeking a highly skilled Clinical Data Manager to join our team. As a key member of our data management team, you will be responsible for ensuring the quality and integrity of clinical data within our electronic data capture (EDC) system.

Key Responsibilities

  • Serve as the primary point of contact for all data management-related matters with clients and study teams.
  • Develop and maintain eCRFs, ensuring compliance with applicable quality validation standards.
  • Define and create data listings, summary table validation, data specifications, and process data transfers for statistical review.
  • Coordinate and execute coding activities, drug safety reconciliation, and data review.
  • Reconcile safety and efficacy data.
  • Collaborate with cross-functional teams to ensure timely and accurate data delivery.

Requirements

  • 7+ years of relevant data management experience in the CRO/pharmaceutical industry.
  • EDC designing and UAT experience required.
  • Proven ability to use statistical software - SAS.
  • Demonstrates knowledge of GCPs and protocol.
  • Strong time management and prioritization skills to meet deadlines.
  • Strong project management and communication skills (verbal/written).
  • Experience in pharmacology and drugs life cycle.
  • Knowledge of ICH-GCP.
  • Strong analytic and quantitative background.
  • Excellent Microsoft Office skills.

Preferred Qualifications

  • Experience working with EDC systems.
  • Knowledge of data management best practices.

What We Offer

  • Competitive hourly rate: $95.00 per hour.
  • Comprehensive benefits package, including 401(k), dental insurance, health insurance, and vision insurance.
  • Flexible scheduling, including 8-hour shifts and Monday to Friday work schedule.

Relocation Requirements

  • Relocation to Menlo Park, CA is required before starting work.

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