Clinical Operation Manager
Clinical Operation Manager
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Job Description
On behalf of our Client a global pharmaceutical company IQVIA is looking for a Clinical Operations Manager (COM) will lead and manage the daytoday operations of clinical trials ensuring compliant of clinical studies.
This individual will be responsible for overseeing all aspects of clinical operations in Italy working crossfunctionally 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 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 trialspecific procedures.
Represent the company at clinical meetings conferences and regulatory agencies as
needed.
Qualifications:
Bachelors degree in Life Sciences Nursing or a related field. Advanced degree (e.g.
Masters) 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.
Indepth knowledge of clinical trial design 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 openended starting with parttime or potentially fulltime contract
(contratto a tempo indeterminato) or fixedterm 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 IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77.
#LICES #LIDNP
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Manager
Employment Type
Full-Time
