Senior Clinical Trial Manager

🔥 0 minutes ago

🇿🇦 South Africa – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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

🎯 Requirements

• 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 • Employment contingent upon having the legal right to work in the country where the role is based

🏖️ Benefits

• 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