Current jobs related to Clinical Safety Data Associate - Markham, Ontario - Everest Clinical Research Services Inc


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

    Job Title: Clinical Safety Data AssociateEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled and customer-focused individual to join our team as a Clinical Safety Data...


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

    Job Title: Clinical Trial Drug Safety AssociateEverest Clinical Research Services Inc is seeking a highly skilled and customer-focused individual to join our team as a Clinical Trial Drug Safety Associate. As a key member of our team, you will be responsible for performing PV and MDV activities for our clients in compliance with company SOPs, working...


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

    Job Title: Clinical Trial Drug Safety AssociateEverest Clinical Research Services Inc is seeking a highly skilled and customer-focused individual to join our team as a Clinical Trial Drug Safety Associate. As a key member of our team, you will be responsible for performing PV and MDV activities for our clients in compliance with company SOPs, working...


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

    Job Title: Clinical Trial Drug Safety AssociateEverest Clinical Research Services Inc is seeking a skilled and customer-focused individual to join our team as a Clinical Trial Drug Safety Associate. This role is responsible for performing PV and MDV activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.Key...


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

    About Everest Clinical Research Services IncEverest Clinical Research Services Inc 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...


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

    Everest Clinical Research Services Inc is a leading contract research organization providing comprehensive clinical research services to pharmaceutical, biotechnology, and medical device industries. As a Senior Clinical Trial Drug Safety Associate, you will be responsible for ensuring compliance with regulatory guidelines and company SOPs in the collection,...

  • Clinical Data Manager

    1 month ago


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

    Job Title: Principal Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled and experienced Principal Clinical Data Manager to join our team. As a key member of our data management team, you will be responsible for ensuring the quality and integrity of clinical trial data.Key Responsibilities:Act as the primary contact person...

  • Clinical Data Manager

    1 month ago


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

    Job Title: Principal Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled and experienced Principal Clinical Data Manager to join our team. As a key member of our data management team, you will be responsible for ensuring the quality and integrity of clinical trial data.Key Responsibilities:Act as the primary contact person...


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

    Everest Clinical Research Services Inc is a leading contract research organization (CRO) providing a wide range of expertise-based clinical research services to the pharmaceutical, biotechnology, and medical device industries worldwide.We are seeking a highly skilled and experienced Senior Clinical Data Manager to join our team in Markham, Ontario, Canada or...

  • Clinical Data Manager

    4 weeks ago


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

    Clinical Data ManagerEverest Clinical Research Services Inc is seeking a skilled Clinical Data Manager to join our team. As a Clinical Data Manager, you will be responsible for planning, managing, and controlling data processing and management activities for assigned projects.Key Responsibilities:Plan and manage data processing and management activities for...


  • 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...


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

    Job Title: Senior Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will be responsible for leading data management activities, performing training, and client relationship management.Key Responsibilities:Develop and...


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

    Job Title: Senior Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will be responsible for leading data management activities, performing training, and client relationship management.Key Responsibilities:Develop and...


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

    Senior Clinical Data ManagerEverest Clinical Research Services Inc is a leading contract research organization (CRO) providing comprehensive clinical research services to the pharmaceutical, biotechnology, and medical device industries. We are seeking a highly skilled and experienced Senior Clinical Data Manager to join our team in Toronto, Ontario,...


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

    Job Title: Clinical Trial Data AnalystWe are seeking a highly skilled Clinical Trial Data Analyst to join our team at Everest Clinical Research Services Inc. As a Clinical Trial Data Analyst, you will be responsible for processing and analyzing clinical trial data to ensure accuracy and compliance with regulatory requirements.Key Responsibilities:Process and...


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

    Job Title: Clinical Trial Data AnalystWe are seeking a highly skilled Clinical Trial Data Analyst to join our team at Everest Clinical Research Services Inc. As a Clinical Trial Data Analyst, you will be responsible for processing and analyzing clinical trial data to ensure accuracy and compliance with regulatory requirements.Key Responsibilities:Process and...


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

    Job OverviewWe are seeking a highly skilled and experienced Clinical Data Management Lead to join our team at Everest Clinical Research Services Inc.About the RoleThe successful candidate will be responsible for overseeing all aspects of clinical data management, ensuring high-quality deliverables and timely project execution. This is a senior-level position...


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

    Job Title: Senior Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will be responsible for leading data management activities, performing training, and client relationship management.Key Responsibilities:Develop and maintain Data...


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

    Job Title: Senior Clinical Data ManagerEverest Clinical Research Services Inc is seeking a highly skilled Senior Clinical Data Manager to join our team. As a Senior Clinical Data Manager, you will be responsible for leading data management activities, performing training, and client relationship management.Key Responsibilities:Develop and maintain Data...


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

    About the Role: At Everest Clinical Research Services Inc, we are seeking a skilled Clinical Data Manager I Lead to join our team of professionals who are passionate about delivering high-quality clinical research services. This is a challenging and rewarding opportunity for individuals who are looking to grow their career in the clinical data management...

Clinical Safety Data Associate

2 months ago


Markham, Ontario, Canada Everest Clinical Research Services Inc Full time
Job Title: Clinical Safety Data Associate

Everest Clinical Research Services Inc is seeking a skilled and customer-focused individual to join our team as a Clinical Safety Data Associate. This role is responsible for developing study safety data review plans, maintaining data review checklists, and performing safety data reviews according to the Safety Data Review Plan.

Key Responsibilities:
  • Develop study safety data review plans and maintain a standard set of data review checklists for clinical trial laboratory data, AEs, SAEs, medical events of special interests, concomitant medications, disease history, and early study termination due to AEs.
  • Perform safety data review according to the Safety Data Review Plan and review safety data in study database, including the review of laboratory data, AEs, SAEs, medical events of special interests, concomitant medications, disease history, and early study termination due to AEs.
  • Coordinate with study Project Managers and Clinical Data Managers to maintain high-quality data collected in clinical trials.
  • Document, report, and follow-up on all issues identified during the review in a timely manner.
  • Provide medical advice when required to the Clinical Data Managers for their work in reconciling SAEs.
  • Perform coding of AEs/medical histories/concomitant diseases using the MedDRA dictionary.
  • Perform coding of medications (e.g., concomitant medications, concomitant therapies, etc.) using the WHODrug dictionary.
  • Coordinate with Data Managers and ensure medical events and medications collected in study database are coded accurately and on a timely basis.
  • Participate in the trial protocol review and the review of trial Case Report Forms (CRFs) or eCRFs (electronic CRFs) and provide input to the requirements for accurate and consistent approaches in laboratory data collection.
  • Provide medical advice to the Clinical Data Manager with writing the Laboratory Edit Specifications, review the specifications to confirm accuracy, completeness, and ensure consistency across all studies.
  • Review and confirm laboratory normal ranges and units from both central laboratories and local laboratories.
  • Coordinate with and assist the Clinical Data Managers in managing local and central laboratory data and resolve related data issues.
  • Assist the Director of Medical Coding to ensure proper version control of the coding dictionaries and keep track of trial Sponsors' requirements on coding dictionaries and ensure compliance on these requirements.
  • Participate in and contribute to Clinical Data Management initiatives.
  • Provide medical and coding support for programming and biostatistics activities and projects as required and needed.
Qualifications and Experience:
  • RN, M.D., M.Sc., or Ph.D. in Pharmacology or in health-related science, Pharm.D., or equivalent education in relevant disciplines.
  • Two to three years' experience in clinical trial data management, including medical coding and laboratory data management.
  • A broad knowledge in clinical trial safety data coding and management.
  • Demonstrated ability to effectively manage medical information; must communicate effectively, orally and in writing, with personnel on all professional and administrative levels; must be well organized and able to work independently and manage multiple projects/tasks appropriately.