Clinical Data Management Specialist

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Clinical Data Management Specialist for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities:

• Perform data entry and processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
• Assist the primary Data Manager in performing data management activities. These activities include, but are not limited to, writing Data Management Plans (DMP; including specifying database integrity checks), designing clinical trial Case Report Forms (CRFs), designing databases, monitoring data flow, and quality control processes.
• Write draft DMPs using standard DMP template.
• Assist in defining and monitoring clinical trial data flow and quality control processes in accordance with corporate standard operating procedures (SOPs), Good Working Practices, and divisional guidelines.
• Assist in designing and reviewing patient CRFs and database schema. Test data capture/entry screens and edit specifications.
• Assist in designing databases following database design standards and conventions that have been established by the company or the trial Sponsor.
• Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.
• Assist in performing data quality control procedures during the trial and additional database closure checks at the end of the study.
• Validate and distribute study monitoring reports to internal and external study team members.
• Assist in resolving data coding discrepancies resulting from the coding of medical events, procedures, and medications.
• Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials.
• and assist the corporate archivist in assembling and archiving such documentation.
• Assist data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema and databases for assigned studies. These QA procedures include, but are not limited to, the following: performing line-by-line checks on subject data listings against completed CRFs; comparing database schema against annotated CRFs; comparing final paper CRFs against CRF images that were captured during the trial.

• A Bachelors’ or Masters’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields. Education or experience must demonstrate the ability to work independently and to apply data management concepts, clinical trial data capture and management techniques, and logical and algebraic operations. .