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Data Management Specialist

2 months ago


Markham, Ontario, Canada Everest Clinical Research Services Inc Full time

About Everest Clinical Research Services Inc

Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a broad range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries. We serve some of the world's most renowned companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Our organization has a strong foundation as a statistical and data management center of excellence, dating back to 2004. Building on this foundation, we have successfully developed and established ourselves as a full-service CRO. Our headquarters are located in a major metropolitan area, with additional sites in other key locations.

We are known in the industry for our high-quality deliverables, superior customer service, and flexibility in meeting clients' needs. A dynamic organization with an entrepreneurial origin, we continue to experience exceptional growth and great success.

Our Mission

Our mission is to provide exceptional clinical research services that meet the highest standards of quality, integrity, and customer satisfaction. We strive to build long-term relationships with our clients and partners, based on trust, respect, and open communication.

Job Summary

We are seeking a highly skilled and experienced Clinical Data Manager to join our team. The successful candidate will be responsible for planning, managing, and controlling data processing and management activities for assigned projects. This will involve leading data processing and management projects, specifying database validation checks, and defining and monitoring clinical trial dataflow and quality control processes.

Key Responsibilities

  • Plan, manage, control, and perform data processing and management activities for assigned projects.
  • Lead assigned data processing and management projects by applying project management skills, data processing, and management techniques.
  • Specify database validation checks for assigned studies.
  • 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.
  • Design and review patient Case Report Forms (CRFs) and database schema.
  • 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.
  • 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.