Clinical Trial Manager

Title – Clinical Trial Operations Manager

Location - Hybrid (Johannesburg - South Africa)

Sponsor dedicated

As a Clinical Trial Operations Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

As a Clinical Operations Manager, you will play a pivotal role in overseeing the execution of clinical trials for studies in Sub-Saharan Africa(based in Johannesburg with minimal travel). You’ll ensure compliance with ICH/GCP regulations, sponsor policies, and high-quality standards while meeting budgetary and regulatory requirements.

Key Responsibilities

• Budget and Contract Oversight:
• Manage country and site budgets, including Clinical Trial Research Agreements.
• Perform financial forecasting and ensure alignment with project goals.
• Regulatory Submissions:
• Supervise clinical trial submissions, approvals, and interactions with IRBs/IECs and regulatory authorities.
• Monitor deliverables, timelines, and output quality to ensure compliance.
• Compliance and Quality Assurance:
• Uphold high standards of quality and regulatory compliance by developing and refining SOPs.
• Ensure adherence to local regulatory and financial requirements.
• Vendor and Supply Chain Management:
• Provide guidance to local vendors and manage ancillary supplies, including import/export, destruction, and insurance processes.
• Coordinate filing, archiving, and retention of essential documents, both electronic and hard copy.
• Leadership and Training:
• Act as a Subject Matter Expert (SME), share best practices, recommend process improvements, and provide training as needed.
• Lead and mentor a team of Clinical Trial Coordinators (CTCs).

Qualifications and Skills

• Expertise:
• Proven knowledge of budget and contract negotiations, regulatory environments, and submission/approval processes, particularly in the study start-up phase.
• Strong understanding of Sub-Saharan Africa’s regulatory landscape is essential.
• Problem-Solving:
• Ability to influence and resolve issues with investigators, vendors, and other stakeholders independently.
• Proactive in identifying risks and implementing mitigation plans.
• Leadership:
• Skilled in managing and guiding a team to achieve project objectives.
• Experience:
• Minimum of 5 years in clinical research, covering responsibilities similar to those outlined above.
• Education:
• A relevant degree in Life Sciences or an equivalent qualification is required.

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
• Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.

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