Clinical Trial Lead Milano

Clinical Trial Lead
Milano
Lombardia, Milano

Competitive

- Milan, Italy

- Permanent

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

**Essential

- _Bachelor's degree in Nursing, Life Sciences or Medical Sciences _

- or equivalent work experience required_

- _Experience as a Clinical Research Associate III_

- _Excellent communication skills_

- _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_

**Desirable

- _Previous CRO experience_

- _Good experience in CTMS, eTMF IXRS and EDC systems_

- _Advanced degree (Masters, MD, PhD)_

- _Strong presentation skills_

- _Competent in clinical trial planning and metrics management_

- _Multiple therapeutic experience and proven ability to gain in-depth protocol knowledge_