Clinical Trial Manager

This is a fully remote position, open to applicants in South Africa.

📋 Description

• Lead country-level initiatives for designated clinical trials within an FSP framework, ensuring adherence to sponsor timelines, quality standards, and operational commitments.

• Serve as the principal operational liaison between ICON and sponsor study teams, effectively escalating risks and issues as necessary.

• Plan, coordinate, and supervise activities related to site feasibility, selection, qualification, initiation, monitoring, co-monitoring, and close-out.

• Ensure that trial execution aligns with sponsor SOPs, ICON processes, ICH-GCP, and local regulatory standards.

• Guide and support CRAs and study support personnel assigned within the FSP model, fostering performance, consistency, and quality.

• Actively identify, evaluate, and manage risks at both the country and site levels, collaborating with sponsor stakeholders to implement mitigation and corrective strategies.

• Review monitoring documentation, study metrics, and reports to guarantee data quality, compliance, and readiness for inspections.

• Aid in recruitment efforts by working closely with investigators, sites, and sponsor stakeholders.

• Participate in country-level planning, forecasting, and execution of timelines, resources, and operational deliverables.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field.

• Demonstrated experience in clinical research, including roles such as senior CRA, lead CRA, or trial management, preferably within an FSP or sponsor-dedicated model.

• A minimum of 3–5 years of experience in project or clinical trial management, with a preference for experience in cardiovascular and respiratory therapeutic areas.

• Comprehensive understanding of ICH-GCP, clinical trial regulations, and specific country requirements.

• Proven capability to manage multiple studies, stakeholders, and priorities within a matrixed operational environment.

• Excellent communication, organizational, and risk-management abilities.

• Willingness to travel both nationally and internationally as required by study obligations.

🏝️ Benefits

• Various annual leave entitlements.

• A selection of health insurance options tailored to meet the needs of you and your family.

• Competitive retirement planning options to enhance savings and help you prepare confidently for the future.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a worldwide network of over 80,000 independent specialized professionals ready to support your 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, and more.