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).