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Avantages offerts par ce poste

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life assurance

Flexible benefits

Résumé du poste

ICON Strategic Solutions is seeking a Senior Clinical Trial Manager to lead country-level delivery in a sponsor-dedicated model. You will drive study start-up through close-out, ensure compliance with ICH GCP and regulatory requirements, and manage budgets and timelines with local teams.

You will oversee site activation, monitoring, TMF/eTMF quality, and collaboration with global study teams, investigators, and vendors to ensure successful patient recruitment and study delivery.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field.
• Significant clinical research experience in CRA/Study Management or Clinical Operations.
• Strong knowledge of ICH GCP, trial regulations, and country-specific rules.
• Proven leadership of cross-functional teams in a matrix environment.

Responsabilités

• Lead and coordinate local study teams to deliver trials on time, budget, and quality.
• Oversee country start-up activities: feasibility, site activation, regulatory submissions.
• Monitor country-level progress, identify risks, implement mitigations, resolve issues.
• Guide CRAs to ensure protocol compliance and regulatory requirements.
• Manage budgets, site contracts, and vendor activities within the country.
• Maintain TMF/eTMF documentation and support inspection readiness.
• Collaborate with global teams to support patient recruitment and study delivery.

Connaissances

Clinical operations leadership

Project management

Cross-functional leadership

Risk mitigation

Stakeholder management

Formation

Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related

Description du poste

Senior Clinical Trial Manager

Remote ICON Clinical Research

Posted today

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 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

**What ICON can offer you:**

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. 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.

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.

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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.