Clinical Data Manager

6 months ago

Markham, Canada Everest Clinical Research Full time

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.

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.
- 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.

We thank all interested applicants, however, only those selected for an interview will be contacted.

LI-Remote
LI-KD1

  • Clinical Data Management Specialist

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Data Management Specialist

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Data Management Specialist

    1 month ago

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

    We are seeking a skilled Clinical Data Manager to join our team at Everest Clinical Research Services Inc. as a Clinical Data Management Specialist.The ideal candidate will have a Bachelor's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields, with at least 2 years of experience in clinical trial data capture and...

  • Clinical Safety Data Associate I

    7 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Senior Clinical Data Analyst

    3 weeks ago

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

    Company Overview\Everest Clinical Research Services Inc. is a leading provider of clinical research services, dedicated to delivering high-quality data analysis and reporting solutions.\Job Summary\We are seeking an experienced Statistical Programmer to join our team in Markham, Ontario. The successful candidate will be responsible for processing and...

  • Principal Data Manager I

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Research Assistant I

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Research Safety Associate

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Trial Iwrs Monitor I

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Trial Iwrs Monitor I

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Trial Drug Safety Associate I

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Data Analysis Lead for Clinical Trials

    1 month ago

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

    Job Summary: As a Senior Statistical Programmer I at Everest Clinical Research Services Inc, you will be responsible for leading efforts in resolving day-to-day work-related issues and problems, ensuring quality of deliverables, as well as improving the efficiency and productivity of statistical programming work. You will lead assigned projects by applying...

  • Senior Clinical Research Statistician

    3 weeks ago

    Markham, Ontario, Canada Everest Clinical Research Full time

    Everest Clinical Research, a renowned full-service contract research organization (CRO), is seeking a highly skilled Senior Clinical Research Statistician to join its dynamic team in Markham, Ontario, or remotely from Canada. As part of our esteemed organization, you will contribute significantly to the success of our clients worldwide by providing...

  • Clinical Trial Statistician

    1 week ago

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

    About the RoleWe are seeking a highly skilled Clinical Trial Statistician to join our team at Everest Clinical Research Services Inc. in Markham, Ontario.Job Summary:The successful candidate will be responsible for processing SDTM and ADaM datasets, conducting statistical analysis, and creating reports based on authorized dataset specifications. They will...

  • Clinical Data Engineer

    4 months ago

    Markham, Canada Astellas Full time

    Clinical Data Engineer Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical...

  • Manager, Biostatistics

    6 months ago

    Markham, Canada Everest Clinical Research Full time

    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...

  • Clinical Project Coordinator

    4 weeks ago

    Markham, Canada Everest Clinical Research-Can Full time

    Everest Clinical Research (“Everest”) is a full-service, global, 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...

  • Clinical Data Engineer

    4 months ago

    Markham, Canada Astellas Pharma Inc. Full time

    Responsibilities :Develop and maintain comprehensive data streaming architecture strategies tailored to the needs of Clinical and Operational data management.Design, develop, and maintain robust data pipelines to ingest, process, and transform clinical data from various sources.Develop and implement data strategies to ensure the accuracy, integrity, and...

  • Senior Clinical Data Analyst

    4 weeks ago

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

    Company OverviewWe are a leading clinical research organization dedicated to advancing healthcare through innovative research and development.

  • Associate Project Manager Ii

    7 months ago

    Markham, Canada Everest Clinical Research-Can Full time

    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...