Senior Manager Risk Based Quality Management

Regulatory Jobs; Center Square (PA); Presencial; USD 140 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Salary incentives

Health coverage

Pension plans

Life & disability

Wellbeing resources

Training programs

Resumo da oferta

ICON Strategic Solutions is seeking a Senior Manager, Clinical Risk Management to identify, assess, and mitigate risks in clinical trials. You will oversee risk strategies, lead a team, and ensure safety and data integrity across sponsor projects.

In this role you will collaborate with clinical operations, regulatory affairs, and data management to integrate risk management into trial processes, staying compliant with GCP and industry standards while driving continuous improvement.

Qualificações

• Degree in Life Sciences, Medicine, Risk Management, or a related field.
• Extensive experience in clinical risk management.
• Proven leadership skills in risk management teams.
• Expertise in regulatory requirements and risk management methodologies.
• Excellent analytical and problem-solving skills.

Responsabilidades

• 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 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.
• Ensuring compliance with regulatory standards and industry best practices for risk management, including adherence to GCP and other relevant guidelines.

Conhecimentos

Clinical risk management

Leadership

Regulatory knowledge

Data analysis

Stakeholder communication

Risk assessment

Problem solving

Formação académica

Life Sciences degree

Descrição da oferta de emprego

Senior Manager Risk Based Quality Management

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Senior Manager, Clinical Risk Management at ICON, you will be crucial in identifying, assessing, and mitigating risks associated with clinical trials.

What You Will Do:

You will oversee scientific operations operations, balancing quality, timelines, and stakeholder expectations.

Key responsibilities include:

• 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:

You will have a strong background in scientific operations, with proven management experience and a commitment to quality delivery.

Required qualifications and experience:

• 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.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.