Clinical Trial Manager

Advanced Clinical; Italia; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global clinical research organization is seeking an experienced Clinical Trial Manager for its oncology-focused studies in Italy. The role includes managing external vendors, preparing study documents, and ensuring compliance with regulations. Candidates should possess a BA/BS degree or nursing qualification along with a minimum of 5 years' experience in clinical studies. Proficiency in tools like TMF and Veeva Vault is essential. A collaborative environment awaits new team members.

Competenze

• Minimum 5 years' experience in clinical studies, including at least 1 year in site management.
• Strong knowledge of GCP and SOPs is essential.
• Advanced proficiency in Word, Excel, and PowerPoint required.

Mansioni

• Manage external vendors and CROs effectively.
• Prepare key study documents and oversee monitoring activities.
• Track patient enrollment and ensure regulatory compliance.

Conoscenze

Vendor management

Operational oversight

Communication skills

GCP knowledge

Cross-functional teamwork

Formazione

BA / BS degree or nursing qualification

Strumenti

TMF

CTMS

Veeva Vault

Smartsheet

SharePoint

Descrizione del lavoro

Clinical Trial Manager – Italy | Advanced Clinical (FSP Model)

Oncology focused

Advanced Clinical is seeking an experienced Clinical Trial Manager to join our UK-based Functional Service Provider (FSP) team. This role will support global clinical studies and requires strong operational, vendor management, and monitoring oversight experience.

Responsibilities include:

• Managing external vendors and CROs
• Preparing key study documents, including Monitoring Manuals, Study Operations Manuals, SDV Plans, and Laboratory Manuals
• Designing and coordinating study materials such as CRFs, patient diaries, source documents, and participation cards
• Assisting with protocol development and study reports
• Overseeing monitoring activities to ensure compliance with GCP, SOPs, and study protocols
• Providing direction and support to CRAs
• Tracking patient enrollment, conducting site qualification / initiation / close-out activities, and supporting data management coordination
• Managing study supplies and negotiating vendor contracts
• Reviewing ICFs, CRFs, and study-related materials
• Planning and participating in investigator meetings
• Supporting the data query process
• Ensuring regulatory compliance and maintaining an up-to-date Trial Master File

Essential Requirements:

• BA / BS degree or nursing qualification (science preferred)
• Minimum 5 years' experience in clinical studies, including at least 1 year of site management
• Previous monitoring or study coordination experience preferred
• Strong knowledge of GCP and SOPs
• Understanding of clinical study phases
• Ability to work independently and within cross-functional teams
• Advanced proficiency in Word, Excel, and PowerPoint
• Experience with electronic systems such as TMF, CTMS, Veeva Vault, Smartsheet, and SharePoint
• Strong communication skills
• Willingness to travel 10–20%

To express interest or learn more about this opportunity, please get in touch. Advanced Clinical offers a collaborative environment where your contributions directly support the success of innovative clinical research.