Clinical Operation Manager page is loaded
Clinical Operation Manager
Apply locations Milan, Italy time type Full time posted on Posted 2 Days Ago job requisition id R1473857
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:
* 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 affairs, quality assurance, and medical affairs teams to ensure clinical trials are conducted in compliance with Italian and EU regulations.
* Conduct training for clinical operations staff 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 Office 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 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).
#LI-CES #LI-DNP
#J-18808-Ljbffr