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Senior Clinical Data Manager
2 months ago
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 Toronto, Ontario, Canada or remotely from a home-based office in Canada.
Key Responsibilities:- Develop and maintain Data Management Project Plans, documenting deviations and issues, and following up on resolutions.
- Lead data management activities, including planning, implementing, and providing status reports on database and data management activities.
- Assist with study-level resource planning and management, reviewing team members' timesheet reports.
- Perform client relationship management activities, participating in project bid defense meetings and providing training on electronic data capture (EDC) systems.
- Develop and maintain data validation specifications, data management plans, and data quality review plans.
- Manage database modifications due to protocol amendments or study needs, and perform serious adverse event reconciliation.
- Assist in resolving medical coding discrepancies and cooperate with the Quality Assurance Department on quality control audits.
- 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 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.
We offer a dynamic work environment, opportunities for growth and development, and a competitive compensation package. If you are a motivated and experienced professional looking for a challenging role, please submit your application.
