At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals - that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.
Abbott Point of Care is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centered environment while driving operational performance. We are headquartered in Princeton, New Jersey, with more than 1,500 global employees and a presence in 84 countries. Our 46,500 square meter, state-of-the-art manufacturing facility, Abbott Point of Care, is located in Ottawa, Ontario, Canada.
Status: Temporary/12 month contract
We are currently seeking a Clinical Data Manager for our Ottawa Clinical Affairs team. 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.
Design and maintain electronic clinical research management databases. Experience in IBM Clinical Development 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 Education and Experience
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.
Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.
Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.
We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.
Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.
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