Senior Clinical Trial Manager

Pharmaceutical Research Associates, Inc; Lecce; In loco; EUR 45.000 - 65.000; Tempo pieno

Descrizione del lavoro

A pharmaceutical research organization in Lecce, Italy is seeking a Senior Clinical Trial Manager to coordinate and lead trial teams, ensuring compliance with protocols and regulatory requirements. Key responsibilities include assessing site suitability, leading trial activities, and supporting vendor processes. Candidates should have a strong background in study management, fluency in Italian, and experience in a relevant therapeutic area. Benefits offered include health insurance and flexible perks.

Servizi

Annual leave

Health insurance

Retirement plans

Flexible benefits

Gym discounts

Competenze

• Experience in a relevant therapeutic area may be required.
• Understanding of drug development, ICH / GCP, and local regulations.
• Minimum 4 years of study management experience.
• Fluency in Italian.

Mansioni

• Assess country feasibility and site suitability.
• Lead local trial activities ensuring compliance with SOPs.
• Monitor trial progress and communicate updates.

Conoscenze

Communication skills

Computer skills

Descrizione del lavoro

Overview

The Senior Clinical Trial Manager is responsible for coordinating and leading the local trial team to deliver quality data and trial documentation that comply with protocols, GCP, SOPs, and regulatory requirements. The role involves process improvement, staff training, mentoring, and may include some site management responsibilities. The Senior CTM performs principal responsibilities under the supervision of the Functional Manager.

Responsibilities

1. Assess country feasibility and site suitability in collaboration with CTA, CRA, and local management, ensuring proper follow-up and site selection recommendations.
2. Collaborate with the CPL, GTM, local management, and Protocol Owner to finalize the site list.
3. Contribute to or develop Trial, Safety Monitoring, Filing, and Investigational Product plans at the country level.
4. Lead local trial activities ensuring compliance with SOPs and Work Instructions, managing recruitment, data quality, and study budget.
5. Ensure timely reporting of SAEs / PQCs and maintain trial management systems like CTMS and eTMF.
6. Monitor trial progress, initiate corrective actions, and communicate updates to study management.
7. Support vendor service requests and vendor selection processes.

Qualifications

• Experience in a relevant therapeutic area may be required.
• Understanding of drug development, ICH / GCP, and local regulations.
• Strong communication and computer skills.
• Minimum 4 years of study management experience.
• Fluency in Italian.

What ICON Offers

ICON values diversity, high performance, and talent development. Benefits include annual leave, health insurance, retirement plans, Employee Assistance Programme, life assurance, and flexible benefits like childcare vouchers and gym discounts. Visit our careers site for more information.

We are committed to an inclusive environment and provide reasonable accommodations for applicants with disabilities. We encourage you to apply even if you do not meet all requirements.

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