Senior Clinical Data Manager

3 days ago


Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time
Senior Clinical Data Manager

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled Senior Clinical Data Manager to join our team in Bridgewater, New Jersey, USA or remotely from a home-based office in the USA.

Key Responsibilities:
  • Develop and maintain Data Management Project Plans, documenting deviations and reporting issues.
  • Lead data management activities, including training and client relationship management.
  • Design and review case report forms, develop and review completion instructions, and generate annotated case report forms.
  • Develop and maintain data validation specifications, data management plans, and data quality review plans.
  • Manage database design, participate in EDC user acceptance testing, and perform database modifications.
  • Review data, issue and resolve queries, and perform serious adverse event reconciliation.
  • Assist in resolving medical coding discrepancies and cooperate with the Quality Assurance Department on quality control audits.
Requirements:
  • Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
  • At least 5 years of experience in pharmaceutical clinical trial data management or 2 years as a Clinical Data Manager II, with demonstrated knowledge and ability to meet high quality standards and customer satisfaction.
  • Demonstrated in-depth understanding of clinical trial data management concepts, processes, and procedures, as well as pharmaceutical clinical trial regulations, industry guidance, conventions, and standards.
What We Offer:

We offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package. If you are a motivated and detail-oriented individual with a passion for clinical data management, we encourage you to apply for this exciting opportunity.



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