Veterans at Abbott
Abbott Clinical Data Manager R&D- Abbott Point of Care (Ottawa) in Ottawa, Ontario
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.
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
Direct communication with site personnel to assist in resolution of queries.
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:
Bachelor of Science in Clinical Research is required
Certification as Clinical Data Manager by the Society of Clinical Data Management is strongly preferred
6 to 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
Excellent English 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.
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.
Computer skills: Intermediate skills in MS Office, SAS, JMP and advanced skills in EDC and CTMS
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