Study Start-Up Manager

Novartis; Milano; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is seeking a dynamic SSO Study Start-Up Manager to oversee local teams and ensure trial startup compliance with regulatory standards. The ideal candidate will have a degree in a scientific discipline and at least five years of experience in clinical operations or project management. This full-time position involves collaboration with various stakeholders and requires strong problem-solving skills within the clinical drug development process.

Competenze

• Minimum of 5 years experience in clinical operations or project management.
• Understanding of trial set-up, execution and monitoring is essential.
• Knowledge of GCP, ICH guidelines and local regulations required.

Mansioni

• Steer SSU processes and ensure compliance with standards.
• Collaborate with various stakeholders to meet project schedules.
• Oversee preparation of submission packages for IRBs and Health Authorities.

Conoscenze

Leading in a matrix environment

Problem-solving

Comprehensive knowledge of clinical drug development

Formazione

Degree in scientific or healthcare discipline

Descrizione del lavoro

Job Description Summary

Novartis seeks a dynamic and experienced SSO Study Start‑Up Manager (SSUM) to join our dedicated team. This pivotal position reports directly to the Study Start‑Up (SSU) Team Lead and leads the local Study Start‑Up teams for designated trials holding significant responsibilities within our organization ranging from trial and budget planning to ensuring on‑schedule completion of trial start‑up activities.

Job Description

Key responsibilities

• The SSUM is responsible for study planning SSU processes and activation of assigned projects ensuring compliance with Novartis standards GCP / ICH guidelines and regulatory requirements.

Your duties will but not be limited to

• Steering all SSUs of assigned projects in close cooperation with the SSO Feasibility Manager SSO Site Partnership Manager and the global study team.
• Backing the country’s SSU strategy working closely with the SSO Study Start‑Up Team Lead SSO SSU Country Head and SSO Country Head Portfolio (Early & Late Stage).
• Collaborating with the SSO Country Head Portfolio SSO Portfolio Team Leads and the global study team to ensure the SSU schedules and results meet country commitments.
• Responsible for timely startup activities from country allocation to the Green Light stage (ready to initiate site) in assigned projects.
• Facilitating close collaboration with local IRBs / IECs and Health Authorities where necessary.
• Ensuring efficient startup activities including overseeing the preparation of initial / amendments submission packages and consent form reviews.
• Coordinating timely responses to deficiency letters working closely with local and global partners.
• Responsible for the timely accurate and high‑quality country TMF documents ensuring readiness for inspection while adhering to financial standards prevailing legislation ICH / GCP guidelines local / National Health Authorities regulations and Novartis standards.

Essential requirements

• A degree in a scientific / healthcare discipline with experience in clinical operations or project management.
• Minimum of 5 years experience in clinical operations in a project management role and / or in monitoring clinical trials.
• Skilled in leading in a matrix environment without direct reports.
• Understanding of all aspects of clinical drug development with a specific emphasis on trial set‑up execution and monitoring.
• Proven problem‑solving skills and ability to handle complex issues.
• Understanding of the international aspects of the drug development process including solid knowledge of international standards (GCP / ICH) Health Authorities (FDA / EMEA) local / National Health Authorities regulations and Novartis standards.

Employment Type: Full‑Time

Vacancy: 1