Clinical Operation Manager

Iss Iqvia Csms; Milano; In loco; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading global pharmaceutical company is seeking a Clinical Operations Manager in Italy. The role involves overseeing clinical trials and ensuring compliance with regulations, while leading a team to achieve quality and operational excellence. Candidates must have significant experience in clinical operations and strong leadership skills.

Servizi

Competitive salary package

Initial temporary contract of 1 year

Competenze

• 5 years of clinical operations experience with at least 2 years in a managerial role.
• Deep knowledge of clinical trial design and GCP.
• Fluency in English and Italian required.

Mansioni

• Lead planning, implementation, and management of clinical trials.
• Oversee site selection, recruitment, and monitoring activities.
• Manage budgets and timelines for clinical trials.

Conoscenze

Leadership

Project Management

Communication

Problem Solving

Attention to Detail

Formazione

Bachelor's degree in Life Sciences

Master’s degree (preferred)

Strumenti

Clinical Trial Management Systems (CTMS)

Microsoft Office Suite

Descrizione del lavoro

On behalf of our client, a global pharmaceutical company, IQVIA is seeking a Clinical Operations Manager (COM) to lead and manage the day-to-day operations of clinical trials, ensuring compliance with clinical study protocols.

This individual will oversee all aspects of clinical operations in Italy, working cross-functionally with internal and external stakeholders to ensure that clinical trials are completed on time, within budget, and in compliance with applicable regulatory requirements.

Responsibilities:

1. Lead the planning, implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
2. Oversee site selection, recruitment, and monitoring activities for clinical trials within Italy.
3. Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies.
4. Provide leadership and mentorship to the clinical operations team, including Clinical Research Associates (CRAs).
5. Manage external service providers such as Contract Research Organizations (CROs), vendors, and clinical trial sites to meet all deliverables.
6. Develop and manage clinical trial budgets and timelines, adjusting as necessary to meet operational needs.
7. Track and report on trial progress, data collection, site performance, and other key metrics to senior leadership.
8. Collaborate with regulatory affairs, quality assurance, and medical affairs teams to ensure compliance with Italian and EU regulations.
9. Conduct training for clinical operations staff on regulatory requirements, company policies, and trial-specific procedures.
10. Represent the company at clinical meetings, conferences, and regulatory agencies as needed.

Qualifications:

• Bachelor's degree in Life Sciences, Nursing, or a related field; Master’s degree preferred.
• Minimum of 5 years of clinical operations experience in the pharmaceutical, biotech, or medical device industry, with at least 2 years in a managerial role.
• Deep knowledge of clinical trial design and regulatory requirements (GCP, ICH, FDA, EMA).
• Strong leadership, project management, and communication skills.
• Fluency in English and Italian (both written and spoken).
• Familiarity with Italian employment laws, including labor contracts, termination procedures, and union agreements.
• Excellent attention to detail, with the ability to manage multiple complex projects simultaneously.
• Proactive problem-solving skills and ability to collaborate across functions.
• Excellent interpersonal skills to build strong relationships with internal and external stakeholders.
• Proficiency with clinical trial management systems (CTMS) and Microsoft Office Suite.

Employment Requirements in Italy:

• Ability to work under an open-ended contract, starting part-time or full-time depending on company needs.

We Offer:

• Competitive salary package commensurate with experience.
• Initial temporary contract of 1 year.

IQVIA reserves the right to evaluate candidates based on domicile, residence, work experience, and educational background relevant to the role. Applications lacking the specified requirements will not be fully considered. Please provide authorization for the processing of personal data as per GDPR (DL196/2003, GDPR 679/2016).

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We aim to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

Required Experience: Manager

Key Skills: Six Sigma, Lean, Management Experience, Process Improvement, Microsoft Outlook, Analysis Skills, Warehouse Management System, Operations Management, Kaizen, Leadership Experience, Supervising Experience, Retail Management

Employment Type: Full-Time

Experience: Years

Vacancy: 1