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Manager Clinical Compliance
4 months ago
**About 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.
**Working at Abbott**
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. We are currently seeking a Manager of Clinical Compliance. In this role you will lead the compliance efforts of the division related to clinical research and prepare and monitor internal and external audits of clinical studies. You will also lead development, implementation and tracking of clinical affairs processes and programs against federal and international guidelines.
**What You’ll Do**
Support Global Clinical Affairs Team in developing, implementing, tracking of compliance processes and program standards as well as local and worldwide regulations and guidelines (i.e. Good Clinical Practice (GCP), International Conference of Harmonization (ICH), and Food and Drug Administration (FDA)).
Provide GCP supervision and guidance for clinical research activities by collaborating with various internal and external groups (e.g. Regulatory, Quality, Clinical Program Managers, CRA managers and study managers).
Maintain a high level of quality and consistency across the clinical studies and programs.
Provide guidance to clinical teams on best practices, industry standards and regulations.
Encourage discussion and evaluate best practices for continuous improvement of quality and compliance across programs.
Prepare and assist / monitor required actions for both for internal audits and external audits Bioresearch Monitoring (BIMO) / FDA and other Notified Bodies.
Oversee audit plans, audit reports and institute any necessary corrective or preventative actions to meet procedural or regulatory compliance requirements.
Review protocol and clinical trial registration documentation for accuracy, completeness, and compliance requirements.
Oversee and review adverse events reporting as per company procedures and regulatory requirements.
May manage a team of 2-4 individuals.
**Required Qualifications**
Bachelor’s degree in scientific or technical discipline is required. Degree in healthcare or medical field is preferred.
Minimum 7 years in performing clinical research or similar work experience in the medical device field audit experience preferred.
Clinical research experience in 510(k) products is desired. In-depth knowledge of the US federal and international regulations related to clinical research.
Proven record of compliance to regulations and guidelines such as Code of Federal Regulation (CFRs), GCPs, ICH guidelines and FDA regulations in clinical studies.
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.
