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Clinical Data Manager

  • Ottawa, ON, Canada

$96,000 to $110,000 CAD / year

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Job details

Pay
$96,000 to $110,000 CAD / year
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Posting language
English
Posted

Original job description

Are you a talented Clinical Data Manager with EDC and clinical trial experience who thrives on accuracy, compliance, and driving research success?Agilus by Synergie is recruiting for a Clinical Data Manager in the Medical Device in Ottawa, Ontario. This opportunity is ideal for an experienced Clinical Data Management professional who is passionate about data integrity and advancing clinical research. You will support all phases of clinical studies, from database design and validation through study closeout, ensuring high-quality, compliant data for statistical analysis. Working closely with cross-functional teams, you will leverage your expertise in EDC systems, CTMS, and regulatory requirements to drive successful study outcomes in a collaborative, fast-paced environment. A typical day:Design and maintain electronic data capture/management databasesMaintenance of data management documentation and archiving clinical trial data and study documentationDesign of case report forms and database validation checks based on an understanding of the therapeutic area of interestValidation of electronically captured data, querying both missing data and data points failing range checks and/or logical checksDesign and provision of resource materials (including source document verification reports and query status reports) to onsite monitors to assist with their onsite activitiesTraining of sites and supporting study team members on data management activities at investigator meetingsEnsure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of junior data management staff, and follow-up of corrective actionsAbility to travel approximately 5% (US and Canada)Successful candidates will have:Bachelors Degree in Health, Clinical, or Biological SciencesTypically requires a minimum of 6 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial ManagementSystems (CTMS) and Clinical Research Data Management or equivalentInternational Harmonized /Committee Good Clinical Practices, IHC/GCPImplementation of FDA Title 21 CFR Part 11 Compliant Data SystemsImplementation of Electronic Data Capture for Clinical StudiesImplementation of Clinical Trial Management Systems for Clinical StudiesTotal rewards:$96000.00 - $110000.00 annuallyBi-Weekly pay including 4% vacation payPreferred rates for benefit coverage availableOpportunity to work for an industry leader1 year contract opportunitySoft skills:Excellent Communications skills, both oral and writtenAbility to initiate, plan and manage projectsStrong decision-making skills and ability to prioritizeAbility to form and develop interpersonal, professional relationships; display socially and professionally appropriate behaviorKnowledge of project management tools and techniquesBroad knowledge and application of business concepts, procedures and practicesMedical Technology, Clinical Laboratory and/or In-Vitro Diagnostics experience preferredThis posting is for an active opening. Interested? Please apply directly online Agilus by Synergie would like to thank all candidates for their interest in this opportunity. Due to the volume of resumes we receive; we may only be able to respond directly to those candidates being selected for an interview.We encourage you to visit agilus.ca regularly or subscribe to our email alerts at agilus.ca/Account/Register as new exciting employment opportunities become available daily.

More about this job

Responsibilities

The Clinical Data Manager at Agilus Work Solutions will design and maintain clinical trial databases, check and query study data, and train sites and staff. The role also keeps data management documents and study records in order.

Requirements

Candidates need a bachelor's degree in health, clinical or biological sciences and about 6 years of clinical data management experience. Experience with EDC, CTMS and FDA 21 CFR Part 11 compliant systems is required.

Skills

  • Electronic data capture (EDC)
  • Clinical trial management systems (CTMS)
  • Clinical research data management
  • ICH Good Clinical Practice (GCP)
  • Case report form (CRF) design
  • Database design and validation
  • Data validation and query management
  • Source document verification
  • Protocol and regulatory compliance
  • Training and mentoring of junior staff
  • Project management tools and techniques
  • Written and oral communication
  • Decision-making and prioritization
  • Medical technology and in-vitro diagnostics

Benefits

  • Bi-weekly pay with 4% vacation pay
  • Preferred rates for benefit coverage

Categories

  • Healthcare
  • Data & Analytics
  • Consulting

Keywords

  • Clinical Data Manager
  • clinical data management
  • EDC
  • electronic data capture
  • CTMS
  • clinical trial management system
  • 21 CFR Part 11
  • GCP
  • ICH GCP
  • clinical trials
  • case report forms
  • database validation
  • data cleaning
  • medical device
  • CRF design
  • clinical research
  • Ottawa
  • contract
  • regulatory compliance
  • study closeout

Seniority

Senior

Perks

  • Generous paid time off

Tools

  • EDC system
  • CTMS
  • Project management tools

Languages

  • English

Fields of study

  • Health sciences
  • Clinical sciences
  • Biological sciences

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