Clinical Data Manager

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

Benefits offered by this job

Medical, dental, and vision coverage

Life & AD&D insurance

Short- & long-term disability

Tuition reimbursement

Fitness reimbursement

Employee assistance program (EAP)

Pension plan

Generous paid time off & sick leave

Performance-based bonus

Job summary

Everest Clinical Research seeks committed Clinical Data Managers for Toronto/Markham, Ontario, with remote work options across Canada. You will plan, manage, and perform data processing, lead data management projects, and ensure QC across trial data in accordance with SOPs.

The role requires a Bachelor’s in health/pharma sciences (or related) with 2+ years in clinical trial data capture and management; a Master’s/PhD is a plus. Strong leadership and data management knowledge are essential.

Qualifications

• Strong leadership in data management projects and teams.
• Deep understanding of clinical data management concepts and regulations.
• Experience with QA procedures on trial data and databases.

Responsibilities

• Plan, manage, and perform data processing and management for assigned projects.
• Lead data processing projects and coordinate activities and timelines.
• Define and monitor dataflow, QC processes, and SOP adherence.
• Design/review CRFs and database schema; test data capture screens.
• Validate electronically captured data and build standard query libraries.
• Train and supervise Data Entry personnel on study procedures and handling.

Skills

Data management

Leadership

Quality assurance

Education

Bachelors degree in health/pharma sciences or related

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 as Clinical Data Managers 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:

• 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.

• 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
• opportunity to earn a performance based bonus

Estimated Salary Range: $60,000 - $95,000.

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.