See more Collapse

Manager Clinical Compliance

1 month ago

Ottawa, Ontario, Canada Abbott Laboratories Full time

About Abbott

Abbott is a leading global healthcare company dedicated to advancing science to enhance people's well-being. We are always focused on the future, anticipating changes in medical science and technology.

Joining Abbott

At Abbott, you can make an impact, grow both personally and professionally, prioritize your well-being and family, express your authentic self, and enjoy a fulfilling life. Here are some of the benefits you'll receive:

  • Opportunities for career advancement within a multinational organization where you can pursue the career of your dreams.
  • A company renowned as an excellent workplace across numerous countries worldwide, recognized as one of the most admired companies globally by Fortune.
  • An organization acclaimed as one of the top large companies to work for, as well as a leader in workplace diversity, particularly supporting working mothers, female executives, and scientists.

The Role

This position is based in Ottawa, Ontario, within the Point of Care Diagnostics division. We are empowering informed medical and economic decision-making to revolutionize how individuals manage their health throughout all life stages. Abbott's diagnostic instruments conduct over 10 million tests daily, delivering lab results to millions.

Our Point of Care diagnostic portfolio covers critical health areas such as infectious diseases, cardiometabolic conditions, informatics, and toxicology. We are currently in search of a Manager specializing in Clinical Compliance. In this role, you will oversee the compliance efforts related to clinical research within the division, conduct and supervise internal and external audits of clinical studies, and direct the development, implementation, and monitoring of clinical affairs processes and programs in alignment with national and international standards.

Key Responsibilities

  • Support the Global Clinical Affairs Team in establishing, implementing, and monitoring compliance processes, standards, and regulations on a local and global scale, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and the Food and Drug Administration (FDA).
  • Provide GCP support and guidance for clinical research operations by collaborating with various internal and external stakeholders.
  • Ensure high quality and consistency across all clinical studies and programs.
  • Offer advice to clinical teams on industry best practices, standards, and regulations.
  • Foster dialogue and assess best practices to enhance quality and compliance across programs continually.
  • Prepare for and assist in internal and external audits, such as Bioresearch Monitoring (BIMO) and FDA audits, and implement necessary corrective actions to ensure compliance with procedures and regulations.
  • Review protocol and clinical trial documentation for accuracy, completeness, and compliance.
  • Supervise and assess adverse event reporting in accordance with company policies and regulatory mandates.
  • Potentially manage a small team of 2-4 individuals.

Requirements

  • Bachelor's degree in a scientific or technical field required; a healthcare or medical background is preferred.
  • Minimum of 7 years' experience in clinical research or related roles within the medical device sector, with audit experience being advantageous.
  • Experience in clinical research involving 510(k) products is a plus.
  • Thorough understanding of US federal and international regulations pertaining to clinical research.
  • Demonstrated compliance with regulations and guidelines such as Code of Federal Regulations (CFRs), GCPs, ICH guidelines, and FDA regulations in clinical studies.

Discover diverse opportunities at Abbott to pursue your professional goals and lead a fulfilling life. Abbott is committed to fostering employee diversity and maintains an inclusive, high-performance culture that enables all employees to realize their full potential and contribute to the company's achievements.

We have other current jobs related to this field that you can find below

  • Clinical Project Manager

    5 days ago

    Ottawa, Ontario, Canada Abbott Laboratories Full time

    About AbbottAbbott 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:...

  • Clinical Project Manager

    4 weeks ago

    Ottawa, Ontario, Canada Adecco Canada Full time

    Adecco is currently hiring for a Project Manager - Clinical Research for our Medical Device Manufacturing client in Ottawa West. This is an opportunity is a 1 year contract offering full time hours, Monday – Friday. The salary for this position will be determined based on education and experience. Our client is a diversified health care innovator with a...

  • Clinical Project Manager

    5 days ago

    Ottawa, Ontario, Canada Adecco Canada Full time

    Adecco is currently hiring for a Project Manager - Clinical Research for our Medical Device Manufacturing client in Ottawa West. This is an opportunity is a 1 year contract offering full time hours, Monday – Friday. The salary for this position will be determined based on education and experience. Our client is a diversified health care innovator with a...

  • Territory Account Manager

    5 days ago

    Ottawa, Ontario, Canada Clinical Research Dental Full time

    Welcome to Clinical Research Dental (CRD) It is our mission to support, promote and teach better dentistry through the presentation of clinical seminars, workshops, and scientific research studies and to provide only clinically proven products to dentists throughout North America via a highly trained and skilled technical support staff.CRD is a Canadian...

  • Territory Account Manager

    5 days ago

    Ottawa, Ontario, Canada Clinical Research Dental Full time

    Welcome to Clinical Research Dental (CRD) It is our mission to support, promote and teach better dentistry through the presentation of clinical seminars, workshops, and scientific research studies and to provide only clinically proven products to dentists throughout North America via a highly trained and skilled technical support staff.CRD is a Canadian...

  • Manager, Supplier Engagement

    3 weeks ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Manager, Supplier Engagement

    2 months ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Manager: Clinic

    5 days ago

    Ottawa, Ontario, Canada Ottawa Humane Society Full time

    Manager: Clinic WHY WORK WITH THE OTTAWA HUMANE SOCIETY? Working with the Ottawa Humane Society, you will join a team of compassionate, driven people dedicated to making a difference for the animals. At the OHS, investing in our people makes it possible for more to be done for animals in need and to prepare for the future. You will enjoy extensive...

  • Quality Compliance Manager

    5 days ago

    Ottawa, Ontario, Canada Collins Aerospace Full time

    Date Posted:Country:CanadaLocation:104-30 Edgewater Drive, Ottawa, Ontario, K2L 1V8, CanadaPosition Role Type:Onsite We are currently searching for a Quality Compliance Manger to join our team in Ottawa, Canada. Employing some of the most talented, dedicated people on the planet is not by chance. People from all over the globe choose Collins Aerospace as the...

  • Clinic Manager

    6 days ago

    Ottawa, Ontario, Canada FYidoctors Full time

    Join FYidoctors as a Clinic Manager in Ottawa-Westboro on a Full-Time, permanent basis. The clinic operates Monday to Friday with the possibility of Saturday hours in the future.The Clinic Manager will guide staff on processes, programs, and products, as well as provide education. The ideal candidate should have prior experience in retail optics as a manager...

  • Senior SEO Manager

    3 weeks ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Senior SEO Manager

    3 weeks ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Senior SEO Manager

    4 weeks ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Senior SEO Manager

    1 month ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Clinical Operations Lead

    5 days ago

    Ottawa, Ontario, Canada Alimentiv Full time

    Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison...

  • Customer Success Manager

    5 days ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Postdoc in clinical sleep research

    5 days ago

    Ottawa, Ontario, Canada Clinical Sleep Research Platform, Royal Ottawa Institute for Mental Health Research Full time

    The Clinical Sleep Research Unit has exciting opportunities for a postdoctoral researcher interested in expanding their expertise in clinical research in the area of sleep, mental health, and neurosciences. The selected candidate will work on interdisciplinary projects centered on sleep phenotyping in various clinical populations (with a focus on brain-heart...

  • Manager, Solutions Engineering

    2 months ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Manager, Solutions Engineering

    3 weeks ago

    Ottawa, Ontario, Canada Assent Compliance Full time

    Company DescriptionSummaryAssent is the leading solution for supply chain sustainability tailored for the world's top-tier, sustainability-driven manufacturers. Hidden risks riddle supply chains, many of which weren't built with sustainability in mind. That's where we step in. With insights from experts, Assent is the tool manufacturers trust for...

  • Clinical Research Facilitator

    5 days ago

    Ottawa, Ontario, Canada University of Ottawa Heart Institute Full time

    Posted date Wednesday, June 5, 2024Deadline Tuesday, June 25, 2024Start date As soon as possibleCompetition number ATF2425Salary Commensurate with experience and qualificationsSupervision Manager, Clinical Research and ComplianceTermTwo years.IntroductionThe Ottawa Heart Institute Research Corporation (OHIRC) is the research arm of the University of Ottawa...