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Stellenbeschreibung
Senior Clinical Trial Manager
Remote ICON Clinical Research
Job Description
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:
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