Senior Clinical Trial Manager

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 Clinical Trial Manager at ICON, you will lead local study teams and oversee the country-level delivery of clinical studies, ensuring agreed timelines, budgets, quality standards and regulatory requirements are met.

What You Will Do:

In this role, you will be responsible for the end-to-end operational delivery of clinical studies at country level, from feasibility and site selection through to study close-out and archiving.

Key responsibilities include:

• Lead and coordinate local study teams, including CRAs and Clinical Study Administrators, to deliver studies according to agreed timelines, budgets and quality standards
• Oversee country and site-level study activities, including feasibility, site identification, qualification, start-up, initiation, monitoring, close-out and archiving
• Coordinate timely ethics committee, IRB and regulatory submissions in collaboration with Regulatory Affairs, ensuring compliance with local requirements
• Manage country-level study plans, budgets, contracts, informed consent documentation, investigational product activities and essential study documentation
• Oversee site monitoring activities, review monitoring visit reports and conduct co-monitoring, accompanied site visits or training visits when required
• Proactively identify and manage study risks, recruitment challenges and operational issues, working with sites, vendors and local and global stakeholders to implement appropriate solutions
• Maintain inspection-ready study documentation and systems, including the CTMS and eTMF, and support audit and regulatory inspection activities

Your Profile:

To succeed in this role, you will bring strong clinical trial management and site monitoring experience, together with the leadership and project management capabilities required to deliver complex clinical studies.

Required qualifications and experience:

• A bachelor’s degree in life sciences or another relevant discipline is essential
• A minimum of five years’ clinical trial management experience, as well as previous experience working as a Clinical Research Associate, coupled with strong Project Management experience
• Strong knowledge of ICH-GCP, the clinical study process, drug development and applicable local regulatory requirements
• Demonstrated experience leading cross-functional study teams and managing timelines, budgets, resources, risks and competing priorities
• Excellent communication, stakeholder management, organisational and problem-solving skills, with the ability to travel nationally and internationally as required
• Must be based in Johannesburg or within a reasonable commuting distance
• Willing and able to travel to the Johannesburg office, as well as nationally and internationally, as required

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#Hybrid

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.

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

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.

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