Data Manager - Clinical

New
  • Location
    Ottawa, Ontario
  • Job type
    Temporary/Contract
  • Category
    Science - Pharmaceutical - Clinical

Adecco is currently hiring for a Clinical Data Manager for our Medical Manufacturing client in Ottawa West. This is a 1-year contract opportunity offering full time hours, Monday – Friday. The salary for this position will be determined based on education and experience. Our client is offering sufficient time to relocate for this role.

The Clinical Data Manager will be responsible for the development, validation and maintenance of Clinical systems used to collect and archive Clinical Data and Records. To qualify for this position, you must have a minimum 6 years in a related role. The individual must be flexible and be able to work in a fast-paced environment with changing priorities.

Our client is a diversified health care innovator with a legacy of pioneering work in medical diagnostics and devices. They are dedicated to advancing innovative with-patient diagnostic technology to improve patient care and system efficiency by fundamentally changing the way health care professionals process patients through their system. 

Clinical Data Manager Responsibilities:

  • Design and maintain electronic clinical research management databases.
  • Maintenance of data management documentation and archiving clinical trial data and study documentation.
  • Design of case report forms and database validation checks based on an understanding of the therapeutic area of interest.
  • Validation of electronically captured data, querying both missing data and data points failing range checks and/or logical checks.
  • Design and provision of resource materials (including source document verification reports and query status reports) to onsite monitors to assist with their onsite activities.
  • Training of sites and supporting study team members on data management activities at two investigator meetings.
  • Direct communication with site personnel to assist in resolution of queries.
  • Design and Maintain Clinical SharePoint Sites
  • Ensure compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
  • Other miscellaneous duties as may be required.
  • Clinical Data Manager Requirements:

  • Undergraduate university Degree (4 year program), or  equivalent experience (e.g. B.Sc. , B. Eng)
  • Requires a minimum of 6 – 10 years of related work experience with a solid understanding of Clinical Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS) and Clinical Research Data Management or equivalent.
  • International Harmonized /Committee Good Clinical Practices, IHC/GCP
  • Implementation of FDA Title 21 CFR Part 11 Compliant Data Systems
  • Experience in Merge EclinicalOS or equivalent highly desirable
  • Implementation of Electronic Data Capture for Clinical Studies
  • Implementation of Clinical Trial Management Systems for Clinical Studies
  • Knowledge of project management tools and techniques.
  • Broad knowledge and application of business concepts, procedures and practices.
  • Intermediate working knowledge of MS Office, SAS and JMP
  • Excellent Communications skills, both oral and written.
  • Ability to initiate, plan and manage projects.
  • Strong decision-making skills and ability to prioritize.
  • Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
  • To be considered for this Clinical Data Manager opportunity in Ottawa West, please Apply Now!

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    • Apply with Adecco

    Reference number CA_EN_1_021956_1575295

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