Senior Clinical Trial Manager

ICON Strategic Solutions; South Africa; On-site; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning options

Global Employee Assistance Programme

Job summary

ICON is seeking a Senior Clinical Trial Manager in South Africa to lead country-level clinical study delivery from start-up to close-out. You will ensure studies comply with protocol requirements, ICH GCP, regulatory standards, and budgets while guiding local study teams.

You will oversee feasibility, site activation, monitoring, and investigator contracts, working with global teams to support patient recruitment and ensure inspection readiness.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline.
• Significant clinical research experience in CRA, Senior CRA, Study Management, or related Clinical Operations role.
• Strong knowledge of ICH GCP, regulatory requirements, and country-specific regulations.
• Proven experience leading cross-functional teams and managing studies across full lifecycle.
• Strong project and stakeholder management with ability to juggle multiple priorities.
• Willingness to travel approximately 25%.

Responsibilities

• Lead and coordinate Local Study Teams to deliver clinical studies on time, within budget and quality.
• Oversee country-level start-up activities including feasibility, site activation, and regulatory submissions.
• Manage study progress, identify risks, and implement mitigation strategies.
• Guide CRAs on site monitoring and compliance with protocols and local regulations.
• Oversee budgets, contracts, site payments, systems, and vendor activities within the country.
• Maintain inspection readiness through TMF/eTMF documentation, audits, and regulatory inspections.
• Collaborate with global teams to support patient recruitment and study delivery.

Skills

Clinical operations leadership

Project management

Cross-functional leadership

Matrix management

Travel readiness

Education

Bachelor’s degree in Life Sciences or related

Job description

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 be responsible for leading country‑level clinical study delivery, ensuring studies are executed in accordance with protocol requirements, ICH GCP, applicable regulatory requirements, budget, timelines, and quality expectations. You will provide leadership to local study teams while driving study execution from start‑up through close‑out and inspection readiness.

What You Will Do

In this role, you will be responsible for the oversight and delivery of clinical studies at the country level, ensuring operational excellence across the study lifecycle.

Key Responsibilities Include

• Lead and coordinate Local Study Teams, including CRAs and study support personnel, to deliver clinical studies according to agreed timelines, budget, and quality standards.
• Oversee country‑level study start‑up activities, including feasibility assessments, site selection, site qualification, regulatory and ethics submissions, and site activation.
• Manage study progress at country level, proactively identifying risks, implementing mitigation strategies, and ensuring timely resolution of operational issues.
• Oversee site monitoring activities and provide guidance to CRAs to ensure compliance with study protocols, ICH GCP, sponsor requirements, and local regulations.
• Ensure appropriate management of study budgets, investigator contracts, site payments, study systems, and vendor activities within the country.
• Maintain inspection readiness through effective oversight of TMF/eTMF documentation, quality management activities, audits, and regulatory inspections.
• Collaborate with global study teams, investigators, vendors, and cross‑functional stakeholders to support patient recruitment and successful study delivery.

Your Profile

To succeed in this role, you will bring strong clinical operations leadership experience, excellent project management skills, and the ability to lead cross‑functional teams in a matrix environment.

Required Qualifications And Experience

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline
• Significant clinical research experience in a Clinical Research Associate (CRA), Senior CRA, Study Management, or related Clinical Operations role.
• Strong knowledge of ICH GCP, clinical trial regulations, and country‑specific regulatory requirements.
• Proven experience leading cross‑functional teams and managing clinical studies across the full study lifecycle.
• Strong project management, stakeholder management, and risk mitigation skills with the ability to manage multiple priorities effectively.
• Willingness to travel as required (approximately 25%)
• 3 - 5 years of experience in project management, with experience in cardiovascular and respiratory therapeutic areas being desirable

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, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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