Sr. Manager, Risk-Based Quality Management

Reposted 5 Days Ago
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Regwood, MD
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
The Senior Manager, Clinical Risk Management will lead a team to develop and implement clinical risk management strategies ensuring trial safety and compliance with regulations.
Summary Generated by Built In
Senior Manager, Clinical Risk Management

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Manager, Clinical Risk Management to join our diverse and dynamic team. As a Senior Manager, Clinical Risk Management at ICON, you will be crucial in identifying, assessing, and mitigating risks associated with clinical trials. You will lead a team dedicated to developing and implementing risk management strategies to ensure the safety and efficacy of clinical research while maintaining compliance with regulatory requirements.

What You Will Be Doing:
  • Developing and overseeing clinical risk management strategies, including risk assessment, mitigation planning, and monitoring to ensure the safety and integrity of clinical trials.
  • Leading a team in identifying potential risks related to clinical trial operations, data integrity, and patient safety, and implementing effective risk management measures.
  • Collaborating with cross-functional teams, including clinical operations, regulatory affairs, and data management, to integrate risk management strategies into overall clinical trial processes.
  • Monitoring and analyzing risk-related data and trends, providing insights and recommendations to senior management to address potential issues and enhance risk management practices.
  • Ensuring compliance with regulatory standards and industry best practices for risk management, including adherence to Good Clinical Practice (GCP) and other relevant guidelines.
Your Profile:
  • Degree in Life Sciences, Medicine, Risk Management, or a related field.
  • Extensive experience in clinical risk management or related roles, with a strong background in assessing and mitigating risks in clinical trials.
  • Proven leadership skills, with experience managing and developing a team focused on risk management and patient safety.
  • Expertise in regulatory requirements, industry standards, and risk management methodologies, with a solid understanding of clinical trial operations.
  • Excellent analytical and problem-solving skills, with the ability to provide strategic recommendations and effectively communicate risk-related insights to stakeholders.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Top Skills

Good Clinical Practice (Gcp)
Regulatory Requirements
Risk Management Methodologies
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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.

We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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