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).