Everest Clinical Research is a full-service contract research organization providing clinical research services to pharmaceutical, biotechnology, and medical device industries. They are seeking a Clinical Data Management Specialist to perform data entry and processing activities, assist in data management tasks, and ensure compliance with trial Sponsors' requirements.
Responsibilities
- Perform data entry and processing activities for assigned projects
- Assist the primary Data Manager in performing data management activities
- Write Data Management Plans (DMP; including specifying database integrity checks)
- Design clinical trial Case Report Forms (CRFs)
- Design databases, monitor 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
- 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
- Perform line-by-line checks on subject data listings against completed CRFs
- Compare database schema against annotated CRFs
- Compare final paper CRFs against CRF images that were captured during the trial
Skills
- 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
Company Overview
- Everest Clinical Research is a firm which conducts clinical research by contract for firms across the globe in fields It was founded in 2004, and is headquartered in Markham, Ontario, CAN, with a workforce of 501-1000 employees. Its website is https://www.ecrscorp.com/.