AdresseAbout Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Ottawa, Ontario location in the Point of Care, Diagnostics division. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics and toxicology. In this role you manage clinical trials required to support 510(k) regulatory submissions to the FDA for newly developed or existing Medical Device IVD products for Abbott. The candidate will oversee activities ranging from protocol development for studies through to report submission completion and contribute to all activities in between.
What You’ll Do
Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations.
Oversees development of clinical documents, including clinical plans, protocols, forms, and reports.
Manages team to prepare for clinical study initiation, execution and close out activities.
Monitors and reports progress of clinical studies and follows up with team members and line managers when issues develop.
Communicates and works with cross-functional teams to resolve issues that arise during clinical studies.
Ensures consistency of clinical study and processes across clinical trials.
Travels as necessary to aid in program facilitation.
The position requires excellent communication skills, the ability to prioritize and work independently. Exposure to Project Management methods, knowledge of statistics would be an advantage as well as experience using the APOC i-STAT or equivalent system.
Required Qualifications:
Post-secondary degree or diploma in Life Sciences, Biochemistry/Chemistry, Nursing, or equivalent.
6+ years’ experience in managing clinical studies or equivalent product development programs. Experience in in vitro diagnostic/medical device related studies is an asset.
Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices is desirable.
Advanced skills in project planning and management, judgment, decision-making, and problem solving.
Working knowledge of new product development methodologies an asset.
Ability to be creative in achieving objectives while ensuring compliance to regulatory requirements and Abbott policies.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
