Clinical Operations Manager

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).

Location: it, IT

Posted Date: 4/18/2025