Sr. Manager, Clinical Compliance

Reposted 10 Days Ago
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Regwood, MD, USA
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
The Senior Manager, Clinical Compliance oversees quality assurance for clinical trials, ensuring compliance with regulatory standards and leading a quality team to maintain high standards.
Summary Generated by Built In
Sr. Manager, Clinical Compliance

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

As a Senior Manager, Quality Assurance at ICON, you will ensure the quality and compliance of clinical trials, interpreting regulatory requirements, and contribute to the advancement of innovative treatments and therapies.


What You Will Do:

You will manage quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards.
Key responsibilities include:

  • Developing and implementing quality assurance strategies and processes to support clinical trial activities.
  • Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
  • Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
  • Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness.
  • Providing leadership and mentorship to quality assurance staff, fostering a culture of excellence and continuous improvement.

Your Profile:

You will have a strong background in quality assurance and compliance, with proven management experience and a commitment to quality delivery.
Required qualifications and experience:

  • Bachelor's degree in a relevant discipline
  • Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a management or leadership role.
  • Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
  • Excellent analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.
  • Exceptional communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels.
  • Willingness to travel as required (approximately 35%)

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

Skills Required

  • Bachelor's degree in a relevant discipline
  • 7 years of experience in quality assurance in the pharmaceutical, biotechnology or CRO industry
  • 3 years in a management or leadership role
  • Strong knowledge of regulatory requirements and guidelines (e.g., ICH-GCP, FDA)
  • Excellent analytical and problem-solving skills
  • Exceptional communication and interpersonal skills
  • Willingness to travel approximately 35%

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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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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