Clinical Operations Manager

On behalf of our Client, a global pharmaceutical company, IQVIA is looking for a Clinical Operations Manager (COM) who will lead and manage the day-to-day operations of clinical trials, ensuring compliant execution of clinical studies.

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

RESPONSIBILITIES:

1. Lead the planning, implementation, and execution of clinical trials, ensuring adherence to timelines, budget, 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 provide leadership and mentorship to the clinical operations team, including clinical research associates (CRAs).
4. Manage external service providers, including Contract Research Organizations (CROs), vendors, and clinical trial sites, ensuring all deliverables are met.
5. Develop and manage clinical trial budgets and timelines, adjusting as necessary to meet operational needs.
6. Track and report on trial progress, data collection, site performance, and other key metrics to senior leadership.
7. Collaborate with regulatory affairs, quality assurance, and medical affairs teams to ensure clinical trials are conducted in compliance with Italian and EU regulations.
8. Conduct training for clinical operations staff on regulatory requirements, company policies, and trial-specific procedures.
9. Represent the company at clinical meetings, conferences, and regulatory agencies as needed.

Qualifications:

1. Bachelor’s degree in Life Sciences, Nursing, or a related field. Advanced degree (e.g., Master’s) preferred.
2. A minimum of 5 years of clinical operations experience in the pharmaceutical, biotech, or medical device industry, with at least 2 years in a managerial capacity.
3. In-depth knowledge of clinical trial design, execution, and regulatory requirements (e.g., GCP, ICH, FDA, EMA).
4. Strong leadership, project management, and communication skills.
5. Fluency in English and Italian (both written and spoken).
6. Familiarity with Italian employment laws, including labor contracts, termination procedures, and union agreements.
7. Strong attention to detail with the ability to manage multiple complex projects simultaneously.
8. Ability to solve problems proactively and collaborate across functional areas.
9. Excellent interpersonal skills, with the ability to build strong relationships with both internal and external stakeholders.
10. Proficiency with clinical trial management systems (CTMS) and Microsoft Office Suite.

Employment Requirements in Italy:

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

We offer:

Competitive salary package, commensurate with experience, starting with a temporary contract of 1 year.

IQVIA reserves the right to evaluate candidates with domicile/residence and work experience/study with requirements responding to the open request. Applications WITHOUT the requirements will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

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