Remote Senior Compliance Lead - Financial Services

Placements24; Gauteng; Remote; ZAR 1.200.000 - 1.800.000; Vollzeit

Benefits dieser Stelle

Remote working

Health insurance

Professional certifications

Zusammenfassung

ICON Strategic Solutions seeks a Senior Clinical Trial Manager to lead country-level delivery of clinical studies in a sponsor-dedicated model. You will drive start-up through close-out, ensuring protocol adherence, ICH GCP, and regulatory compliance while managing budgets and vendor activities.

You will oversee local teams, monitor progress, mitigate risks, and maintain inspection readiness. Travel ~25% and a focus on cardiovascular/respiratory areas are valued.

Qualifikationen

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related scientific discipline.
• Significant clinical research experience in 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 ability to manage multiple priorities.
• Willingness to travel approx. 25%.
• 3–5 years of experience in project management with cardiovascular and respiratory therapeutic areas desirable.

Aufgaben

• Lead Local Study Teams to deliver studies according to timelines.
• Oversee country-level start-up activities including feasibility, site selection, ethics submissions, and activation.
• Manage country-level study progress, identify risks, and implement mitigations.
• Oversee site monitoring and guide CRAs to ensure protocol compliance and regulatory requirements.
• Ensure management of budgets, contracts, site payments, systems, and vendor activities.
• Maintain inspection readiness through TMF/eTMF documentation and audits.
• Collaborate with global study teams to support patient recruitment and study delivery.

Kenntnisse

Project management

Stakeholder management

Risk mitigation

Cross-functional leadership

Travel willingness

Lifecycle management

Ausbildung

Bachelor's degree in Life Sciences

Nursing/Pharmacy degree

Jobbeschreibung

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 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:

• Lead and coordinate Local Study Teams, including CRAs and study support personnel, to deliver clinical studies according to agreed timelines.
• 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:

• 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.

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.

Benefits:

• Competitive salary package for a remote position.
• Full remote working flexibility, allowing work from any location.
• Comprehensive medical aid and retirement fund benefits.
• Opportunities for professional certifications and ongoing training in compliance.
• A dynamic and supportive virtual work environment focused on regulatory excellence in Nelspruit.

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. In addition to your competitive salary, ICON offers a range of additional benefits. 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.

What ICON can offer you:

Our success depends on the quality of our people. In addition to your competitive salary, ICON offers a range of additional benefits. 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.

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