Clinical Data Manager

Everest-Clinical-Research; Markham; Hybrid; CAD 60,000 - 95,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life & AD&D insurance

Disability insurance

Tuition reimbursement

Fitness reimbursement

EAP

Pension plan

Paid time off

Performance-based bonus

Job summary

Everest Clinical Research in Canada is seeking Clinical Data Managers for Toronto/Markham, Ontario, on-site or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Plan, manage data processing and quality control for assigned projects, lead data management efforts, and design CRFs and database schemas. You will validate data, write queries, and ensure QA procedures while training junior staff and coordinating with sponsors.

Qualifications

• Bachelor's degree with 2+ years' experience in clinical trial data capture and management, or Master/PhD with 1+ year relevant experience.
• Strong understanding of clinical trial data management concepts and regulations.
• Proven leadership in data management projects.

Responsibilities

• Plan, manage, and perform data processing and management activities for assigned projects.
• Lead data processing and management projects, manage timelines and coordinate activities.
• Design and review CRFs and database schema; test data capture screens.
• Validate electronically captured data; write queries for missing data and out-of-range checks; build a standard query library.
• Train and supervise Data Entry personnel and junior data management staff.
• Prepare study progress reports and assist in archival of study data and documents.

Skills

Leadership in data management

Clinical data management concepts

Regulatory compliance understanding

Education

Bachelor's degree in health/pharmaceutical sciences

Master's or Ph.D in 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 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 committed, skilled, and customer-focused individuals to join our winning team asClinical Data Managersfor 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:

• Plan, manage, control, and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
• Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques. Manage timelines and coordinate activities for assigned projects.
• Specify database validation checks for assigned studies. Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.
• Define and monitor clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines. Perform clinical trial site monitors’ training on dataflow and QC processes.
• Design and review patient Case Report Forms (CRFs) and database schema. Test data capture/entry screens.
• 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. Lead efforts in building a standard query library for common database modules, as well as for therapeutic/drug area specific modules.
• Perform QC procedures on assigned database during the trial and additional database closure checks at the end of the study.
• Train and supervise Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data.
• Validate and distribute study progress status reports to internal and external study team members.
• Assist in resolving data coding discrepancies resulting from the coding of medical events, treatment 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 clinical trial data and study documentation.
• Cooperate with and assist, when required, data management quality assurance (QA) personnel in performing QA procedures on trial CRFs, database schema, and databases for assigned studies.

Qualifications and Experience:

• A Bachelors’ degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields with at least 2 years experience in clinical trial data capture and management, or a Master’s or Ph.D degree in these fields with at least 1 year relevant experience.
• In-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards.
• Strong leadership in clinical data management activities and a desire to excel in leading data management projects.

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: $60,000 - $95,000.

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.