Clinical Data Management Specialist

Job summary

The Clinical Data Management Specialist performs data entry, processing, and quality control activities for clinical trials in compliance with sponsor requirements. They assist in designing databases, writing data management plans, and validating electronically captured data to ensure high-quality study deliverables.

Job details

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 Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe. 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: 1. 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. 2. 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. 3. Write draft DMPs using standard DMP template. 4. 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. 5. Assist in designing and reviewing patient CRFs and database schema. Test data capture/entry screens and edit specifications. 6. Assist in designing databases following database design standards and conventions that have been established by the company or the trial Sponsor. 7. 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. 8. Assist in performing data quality control procedures during the trial and additional database closure checks at the end of the study. 9. Validate and distribute study monitoring reports to internal and external study team members. 10. Assist in resolving data coding discrepancies resulting from the coding of medical events, procedures, and medications. 11. Maintain and prepare for final archival of data management documentation relevant to the assigned clinical trials 12. and assist the corporate archivist in assembling and archiving such documentation. 13. 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. Qualifications and Experience: 1. 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 & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including 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, and the opportunity to earn a performance based bonus. Estimated Salary Range: $45,000 - $70,000. To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com [http://www.everestclinical.com] We thank all interested applicants, however, only those selected for an interview will be contacted. Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process. #LI-KD1

What you’ll do

The Clinical Data Management Specialist performs data entry, processing, and quality control activities for clinical trials in compliance with sponsor requirements. They assist in designing databases, writing data management plans, and validating electronically captured data to ensure high-quality study deliverables.

Requirements

Candidates must hold a Bachelor's or Master's degree in health, pharmaceutical, physical, biological, or chemistry fields. The role requires the ability to work independently and apply clinical trial data management techniques and logical operations.

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• AD&D insurance
• Short-term disability
• Long-term disability
• Tuition reimbursement
• Fitness reimbursement
• Employee assistance program
• Pension plan
• Paid time off
• Sick leave
• Performance based bonus

Listed skills

• data management · Preferred
• Data entry · Preferred
• Quality Control · Preferred
• Data Validation · Preferred
• Quality assurance · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Data management
• Clinical trial data
• Case report forms
• Database design
• Data entry
• Quality control
• Data validation
• Medical coding
• Data management plans
• Database integrity checks
• Clinical research
• SOP compliance
• Documentation management
• Quality assurance
• Quality Control Processes
• Time Off Management
• Medical Devices
• Research
• Chemistry
• Biotechnology
• Biology
• Biopharmaceuticals
• Management
• Customer Service
• Clinical Data Management
• Clinical Research
• Clinical Trials
• Data Entry
• Dataflow
• Data Management
• Data Management Plan
• Data Quality
• Database Design
• Database Schema
• Case Report Forms
• Employee Assistance Programs
• Standard Operating Procedure
• Missing Data
• Operations
• Pharmaceuticals
• Pharmaceutical Sciences
• Quality Assurance
• Safety Assurance
• Test Data Generation
• Writing
• Data Capture

Job areas

• Healthcare
• Science & Research
• Data & Analytics
• Clinical Data Management Manager
• Clinical Data Specialist
• Medical Records and Health Information Technicians
• Clinical Data Managers
• Data Scientists

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