Clinical Trial Lead

Meet Recruitment; Milano; In loco; EUR 50.000 - 85.000; Tempo pieno

Descrizione del lavoro

A leading recruitment agency seeks a Clinical Trial Lead to manage clinical operations. The successful candidate will oversee clinical monitoring processes, ensure project deadlines, and collaborate with multiple stakeholders. This role requires a strong background in clinical research and excellent communication skills for effective coordination.

Competenze

• Experience as a Clinical Research Associate III.
• Expert knowledge of clinical research regulations and ICH-GCP.
• Proficiency in written and spoken English; fluent in host country language.

Mansioni

• Responsible for oversight of CRA and IHCRA activity on the assigned study.
• Ensures all monitoring tasks are delivered on time and within agreed budget.
• Communicates progress and assists Project Manager with project tracking.

Conoscenze

Problem-solving

Communication

Mentoring

Relationship management

Formazione

Bachelor’s degree in Nursing, Life Sciences or Medical Sciences

Advanced degree (Masters, MD, PhD)

Strumenti

CTMS

eTMF

IXRS

EDC systems

Descrizione del lavoro

We are looking for a Clinical Trial Lead to join our Clinical Operations team where you will be responsible for managing the planning, implementation, and tracking of the clinical monitoring process. You will maintain an overview of ongoing tasks within the Clinical Operations department and acts as a guide to Clinical Research Associates and In-House Clinical Research Associate activities.

You will work closely with Project Management, Business Development and the Sponsor and will play a significant role in ensuring that deadlines of projects are met in accordance with contracted scope of work, budgeted hours whilst ensuring maximum efficiency and quality.

• KEY ACCOUNTABILITIES
• Responsible for oversight of CRA and IHCRA activity on the assigned study.
• Responsible for the Preparation, maintenance and execution of Clinical Operations plans.
• Ensures study team receives study specific training according to Simbec-Orion SOPs.
• Ensures all monitoring tasks are delivered on time and within agreed monitoring budget.
• Communicates progress and assist Project Manager with tracking of project status.
• Assist Project Manager with budgeting throughout the project and forecasting of URFs.
• Contributes to regular updates to Clinical Trial Systems.
• Act as a CRA on the project, where necessary.
• SKILLS REQUIRED
• Bachelor’s degree in Nursing, Life Sciences or Medical Sciences _
• Experience as a Clinical Research Associate III_
• Proficiency in written and spoken English; fluent in host country language_
• Expert knowledge of relevant clinical research regulations and ICH-GCP_
• Ability to establish / maintain good relationships with sites / colleagues / clients_
• Ability to make decisions independently / Strong problem-solving skills_
• Highly developed mentoring and motivational skills_
• Previous CRO experience_
• Good experience in CTMS, eTMF IXRS and EDC systems_
• Advanced degree (Masters, MD, PhD)_
• Competent in clinical trial planning and metrics management_
• Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge_