Senior Clinical Trial Manager

Pharmaceutical Research Associates, Inc; Logroño; Presencial; EUR 50.000 - 80.000; Jornada completa

Descripción de la vacante

Join a leading clinical research organization as a Senior Clinical Trial Manager, overseeing oncology trials. In this role, you will be responsible for developing operational plans, managing trial activities, and ensuring compliance with clinical regulations, while driving high-quality data delivery and operational excellence.

Servicios

Health insurance options

Retirement plans

Global Employee Assistance Programme

Life assurance

Childcare vouchers

Gym discounts

Formación

• 5+ years of experience in Clinical Operations, preferably in Oncology.
• Strong knowledge of ICH-GCP and FDA guidelines specific to oncology.
• Experience managing clinical trials from start-up to closeout.

Responsabilidades

• Oversee all aspects of international clinical trials, ensuring timely delivery of high-quality data.
• Develop operational plans and collaborate with cross-functional teams.
• Manage trial start-up activities and ensure compliance with regulations.

Conocimientos

Project Management

Communication

Interpersonal Skills

Analytical Skills

Educación

Bachelor's or higher degree in a relevant scientific field

Herramientas

Veeva CTMS

Descripción del empleo

As a Senior CTM, you will join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Partner with Clinical Study Management to oversee all aspects of international clinical trials, ensuring high-quality data delivery on time and within budget.
• Develop and execute operational plans for oncology clinical trials.
• Collaborate with cross-functional teams including data management, clinical scientists, regulatory, and investigators to ensure operational excellence.
• Manage trial start-up activities, including site selection, feasibility, and documentation, in collaboration with Site Engagement & Monitoring Excellence and Supplier Relationship Management.
• Ensure efficient study site initiation, training, and monitoring, adhering to protocols and regulatory standards.
• Build and maintain relationships with investigators and site personnel to facilitate patient recruitment and retention.
• Monitor study progress, identify risks, and implement corrective actions.
• Ensure compliance with ICH-GCP, FDA guidelines, and other regulations throughout the trial lifecycle.
• Coordinate with external vendors like CROs and laboratories for trial deliverables.
• Contribute to study document development, including protocols and SOPs.
• Prepare study materials and maintain study files, including the Trial Master File.

Qualifications

• Bachelor's or higher degree in a relevant scientific field.
• At least 5 years of experience in Clinical Operations, preferably in Oncology.
• Strong knowledge of clinical trial regulations, ICH-GCP, FDA guidelines specific to oncology.
• Experience managing clinical trials from start-up to closeout.
• Excellent project management, communication, and interpersonal skills.
• Detail-oriented with strong analytical skills.
• Proficiency in Veeva CTMS preferred.
• Understanding of oncology treatments and terminology.

What ICON Offers

We prioritize a diverse, inclusive culture that rewards high performance and nurtures talent. Benefits include:

• Various leave entitlements
• Health insurance options
• Retirement plans
• Global Employee Assistance Programme
• Life assurance
• Optional benefits like childcare vouchers, gym discounts, etc.

We are committed to an inclusive environment and equal opportunity employment. If you need accommodations during the application process, please let us know.