Clinical Data Management Specialist

Everest Clinical Research is a full-service contract research organization providing expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. The Clinical Data Management Specialist will perform data entry and processing activities, assist in data management activities, 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

Benefits

• Medical, dental, and vision coverage
• Life & AD&D insurance
• Short- and long-term disability
• Tuition reimbursement
• Fitness reimbursement
• Employee assistance program (EAP)
• A pension plan
• Generous paid time off and sick leave
• The opportunity to earn a performance based bonus

Company Overview