WEP Clinical

Clinical Data Manager

WEP Clinical

full-time

Posted on:

Origin:  • 🇨🇦 Canada

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Lead comprehensive data management activities for multiple clinical trials, ensuring regulatory compliance and data quality.
  • Plan, develop, test, and validate clinical databases and EDC systems to meet trial needs.
  • Collaborate with clients and cross-functional teams on study design, eCRF design, and data cleaning.
  • Monitor and ensure data quality, accuracy, and timely database entries from study sites.
  • Manage external vendors to deliver quality services within project timelines.
  • Maintain regular communication with clients to update on milestones and progress.
  • Ensure adherence to GCP, ICH, and regulatory requirements, supporting audits and inspections.
  • Proactively track study timelines, managing risks and deviations effectively.
  • Contribute to process improvement by developing systems, SOPs, and guidance documents.
  • Support business development activities, including preparing presentations and bid defense materials.

Requirements

  • Bachelor’s Degree in a related field
  • Knowledge of GCP and ICH guidelines.
  • Experience in data review and cleaning activities
  • Proficiency in MS Office suite and data capture systems.
  • Experience in clinical research, preferably with pharmaceutical or medical device companies, hospitals or CROs.
  • Familiarity with statistics, programming, and field monitoring
  • Effective communication skills and leadership skills