Clinical Data Management Specialist

Everest New Logo; Markham; Hybrid; CAD 45,000 - 70,000; Full time

Benefits offered by this job

medical coverage

dental coverage

vision coverage

life & AD&D insurance

short- and long-term disability

tuition reimbursement

fitness reimbursement

employee assistance program (EAP)

pension plan

generous paid time off and sick leave

performance-based bonus

Job summary

Everest Clinical Research is seeking a Clinical Data Management Specialist for Toronto/Markham, Ontario, on-site or remotely from a home-based office anywhere in Canada under the Work from Home policy.

You will perform data entry, assist the Data Manager with DMPs, CRFs, databases, and data flow, and ensure study data quality and QA across trials. A health/pharma degree is required, with independent work capability.

Qualifications

• Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
• Ability to work independently and apply data management concepts, clinical trial data capture and management techniques, and logical and algebraic operations.

Responsibilities

• Perform data entry and processing for assigned projects.
• Assist data manager with DMPs, CRFs, databases, data flow and QA processes.
• Assist in defining and monitoring trial data flow and quality control per SOPs and guidelines.
• Assist in designing CRFs and database schema; test data capture/entry screens.
• Validate electronically captured data and write queries for missing data/tests.
• Maintain and prepare archival of data management documentation and assist archivist.
• Assist QA personnel in performing QA on CRFs and database schemas.

Skills

Data management

CRF design

QA and data quality

Education

Bachelor's or Master's degree in health/pharmaceutical sciences or related field

Job description

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.

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.
• 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.

Qualifications and Experience:

• 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:

• medical coverage
• dental coverage
• 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
• 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

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.