Senior Clinical Trial Manager

ICON; Vercelli; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A clinical research organization in Italy is seeking a Senior Clinical Trial Manager to coordinate local trial activities, ensure compliance with regulatory requirements, and foster high-quality data delivery. The ideal candidate has a minimum of 4 years of study management experience and fluency in Italian. This role offers a competitive salary and various benefits, including health insurance and employee assistance programs.

Servizi

Competitive salary

Health insurance

Retirement plans

24/7 Employee Assistance Programme

Gym discounts

Competenze

• Basic understanding of drug development, ICH/GCP, and local regulatory requirements.
• Minimum 4 years of study management experience.

Mansioni

• Coordinate and lead the local trial team to deliver quality data.
• Assess country feasibility and site suitability in collaboration with various roles.
• Maintain and update trial management systems and analyze trial progress.

Conoscenze

Strong communication

Computer skills

Fluency in Italian

Descrizione del lavoro

Senior Clinical Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documents / records that are compliant with assigned protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements. The Senior CTM actively contributes to process improvement, staff training, and mentoring. They may have some site management responsibilities and usually perform principal duties under the supervision of a Functional Manager.

The role includes :

1. Assessing country feasibility and site suitability in collaboration with CTA, CRA, and local management, ensuring consistent conduct of pre-trial assessments and follow-up.
2. Collaborating with the CPL, GTM, and Protocol Owner to select the final site list.
3. Contributing to the development of Trial, Safety Monitoring, Filing, and Investigational Product plans at the country level.
4. Leading local trial activities to meet recruitment targets, deliver high-quality data, and stay within budget, including developing procedures, recruitment planning, risk management, and budgeting.
5. Ensuring timely reporting of Serious Adverse Events (SAEs) and Product Quality Complaints (PQC).
6. Maintaining and updating trial management systems and analyzing trial progress using available tools and reports.
7. Monitoring trial progress, initiating corrective actions, and communicating issues to management.
8. Supporting vendor service requests and selection processes.

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Qualifications include :

• Basic understanding of drug development, ICH / GCP, and local regulatory requirements.
• Strong communication and computer skills.
• Minimum 4 years of study management experience.
• Fluency in Italian.

What ICON offers :

We prioritize diversity, high performance, and talent development. Benefits include competitive salary, various leave entitlements, health insurance, retirement plans, 24/7 Employee Assistance Programme, life assurance, and flexible benefits like childcare vouchers, gym discounts, and travel passes. For more information, visit our careers benefits page.

ICON is committed to inclusion and equal opportunity. We welcome applications from all qualified candidates and provide accommodations for those who need them during the application process.

Interested but unsure? We encourage you to apply regardless, as you may be exactly what we're looking for.

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