Remote Senior Systems Administrator (Cloud & Security)
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Stellenbeschreibung
Senior Clinical Trial Manager
About the Role
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.
Key Responsibilities
- 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.
Benefits
- Competitive salary and performance‑based bonuses.
- 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, subsidised travel passes, health assessments, among others.
Equal Employment Opportunity
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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
We also offer an equal employment policy as per US federal law. Persons are recruited, hired, assigned and promoted without regard to race, colour, age, sex or gender, sexual orientation, gender identity, gender expression, transgender status, religion, creed, national origin, ethnicity, citizenship, ancestry, disability, genetic information, military or veteran status, pregnancy, marital or familial status, or any other protected category under applicable law.