Reg. & Start Up Manager - IQVIA Medtech (Remote from everywhere in Italy)
Reg. & Start Up Manager - IQVIA Medtech (Remote from everywhere in Italy)
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Job Description
Regulatory and StartUp Manager
Job Overview
Responsible for countrylevel Site Activation (SA) activities ensuring compliance with local/international regulations SOPs project requirements and budgetary guidelines. May also support site maintenance activities.
For this role it is mandatoryto have Medical Devices and In Vitro Diagnostic (IVD) prior experience.
We are currently looking for a Specialist and a Manager role with similiar experience but different seniority so based on the interview feedback you could be considered for a Specialist or a Manager role. Apply or ask for information to
Essential Functions
- Act as theSingle Point of Contact (SPOC)for assigned studies coordinating with investigative sites Site Activation Managers (SAMs) Project Management and other departments.
- Executestartup and site activation tasksin line with regulations SOPs and work instructions.
- Prepare and reviewregulatory documentationfor accuracy and completeness.
- Maintaininternal systems and tracking toolswith uptodate project information.
- Monitorsite performance metricsand provide feedback to management.
- Supportproject planning and timeline development including risk mitigation strategies.
- Notify teams uponcompletion of regulatory and contractual documentationfor each site.
- Track and follow up onregulatory ethics ICF and IP release documentsto meet project timelines.
- Offerlocal regulatory expertiseduring planning and execution phases.
- Conductquality controlof sitesubmitted documents.
- May liaise directly with sponsors on specific initiatives.
Qualifications
- 3 years of Regulatory & Start Up experience including1 year in a study leadership role; or equivalent education and experience.
- Strong understanding ofclinical systems procedures and corporate standards.
- Excellentcommunication and negotiation skills with the ability to challenge constructively.
- Proven ability toprioritize multitask and work independently.
- Solid knowledge ofGCP/ICH guidelinesand applicable regulatory requirements.
- Experience in adapting ICFs.
- Familiarity withlocal regulations SOPs and corporate standards.
- Understanding of theclinical trial environmentand drug development process.
- Strong interpersonal skills and ability to build effective working relationships.
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
