JOB DESCRIPTION:

The Opportunity

This position is based at our Ottawa office within the Point of Care division and requires on-site presence four days per week, with the option to work remotely one day. The Point of Care, Diagnostics division empowers smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including Chemistry, Electrolytes, Hematology, Blood Gases, Coagulation, Endocrinology, Cardiac Markers, Neurology, and Informatics. As the Clinical Data Manager on our Clinical Affairs team, you'll have the chance to develop, validate and maintain the Clinical systems used to collect and archive Clinical Data and Records.

What You'll Do
• Design and maintain electronic clinical research management databases. Experience in Zelta EDC or equivalent clinical electronic data capture systems is highly desirable.
• 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.

Required Qualifications
• 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.
• Member of Society for Clinical Data Management (CCDM Certification preferred)
• International Harmonized /Committee Good Clinical Practices, IHC/GCP.
• Implementation of FDA Title 21 CFR Part 11 Compliant Data Systems.
• 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.
• Programming experience in any of the following: SAS, SAS JMP, R, Python.
• Excellent Communications skills, both oral and written.
• Ability to initiate, plan and manage projects.
• Strong decision-making skills and ability to prioritize.
• Prior experience in handling clinical data from IVD type studies would be considered.

The annual base salary for this position ranges from $87,000.00 to $127,600.00 CAD. The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.

The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Clinical Affairs / Statistics

DIVISION:
APOC Point of Care

LOCATION:
Canada > Ottawa : 185 Corkstown Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
M-F (Canada)

TRAVEL:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)