Regulatory and Start-Up Manager
Job Overview
Responsible for country-level 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 mandatory to 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 [email protected].
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.
- Executestart-up and site activation tasksin line with regulations, SOPs, and work instructions.
- Prepare and reviewregulatory documentationfor accuracy and completeness.
- Maintaininternal systems and tracking toolswith up-to-date 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 site-submitted documents.
- May liaise directly with sponsors on specific initiatives.
Qualifications
- 3+ years of Regulatory & Start Up experience, including1+ year in a study leadership role
- 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 https://jobs.iqvia.com
Originally posted on Himalayas
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