IX-063 Clinical Operations Manager
Pubblicato il 21-03-2025 - IQVIA Italia in Roma

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a

Clinical Operations Manager (COM)

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:

- Lead the planning, implementation, and execution of clinical trials, ensuring adherence to timelines, budget, and quality standards.

- Oversee site selection, recruitment,



and monitoring activities for clinical trials within Italy.

- Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and company policies.

- Provide leadership and mentorship to the clinical operations team, including clinical research associates (CRAs).

- Manage external service providers, including Contract Research Organizations (CROs), vendors, and clinical trial sites, ensuring all deliverables are met.

- Develop and manage clinical trial budgets and timelines, adjusting as necessary to meet operational needs.

- Track and report on trial progress, data collection, site performance, and other key metrics to senior leadership.

- Collaborate with regulatory aJairs, quality assurance, and medical aJairs teams to ensure clinical trials are conducted in compliance with Italian and EU regulations.

- Conduct training for clinical operations staJ on regulatory requirements, company policies, and trial-specific procedures.

- Represent the company at clinical meetings, conferences, and regulatory agencies as needed. Qualifications

:

- Bachelor’s degree in Life Sciences, Nursing, or a related field. Advanced degree (e.G., Master’s) preferred.

- 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.

- In-depth knowledge of clinical trial design, execution, and regulatory requirements (e.G., 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. Additional Skills & Competencies:

- Strong attention to detail with the ability to manage multiple complex projects simultaneously.

- Ability to solve problems proactively and collaborate across functional areas.

- Excellent interpersonal skills, with the ability to build strong relationships with both internal and external stakeholders.

- Proficiency with clinical trial management systems (CTMS) and Microsoft OJice Suite. Employment Requirements in Italy:

- Ability to work under an open-ended, starting with part-time or potentially full-time contract (contratto a tempo indeterminato) or fixed-term contract (contratto a tempo determinato), depending on the needs of the company. We offer:

- Competitive salary package, commensurate with experience. - Starting with a temporary contract 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).

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