Offer summary

Qualifications:

3+ years of Regulatory & Start Up experience, including 1+ year in a study leadership role., Strong understanding of clinical systems, procedures, and corporate standards., Excellent communication and negotiation skills, with the ability to challenge constructively., Solid knowledge of GCP/ICH guidelines and applicable regulatory requirements..

Key responsibilities:

Act as the Single Point of Contact (SPOC) for assigned studies, coordinating with various stakeholders.

Execute start-up and site activation tasks in compliance with regulations and SOPs.

Prepare and review regulatory documentation for accuracy and completeness.

Monitor site performance metrics and provide feedback to management.

Job description

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 matteo.massetti@iqvia.com.

Essential Functions

Act as the Single Point of Contact (SPOC) for assigned studies, coordinating with investigative sites, Site Activation Managers (SAMs), Project Management, and other departments.
Execute start-up and site activation tasks in line with regulations, SOPs, and work instructions.
Prepare and review regulatory documentation for accuracy and completeness.
Maintain internal systems and tracking tools with up-to-date project information.
Monitor site performance metrics and provide feedback to management.
Support project planning and timeline development, including risk mitigation strategies.
Notify teams upon completion of regulatory and contractual documentation for each site.
Track and follow up on regulatory, ethics, ICF, and IP release documents to meet project timelines.
Offer local regulatory expertise during planning and execution phases.
Conduct quality control of site-submitted documents.
May liaise directly with sponsors on specific initiatives.

Qualifications

3+ years of Regulatory & Start Up experience, including 1+ year in a study leadership role; or equivalent education and experience.
Strong understanding of clinical systems, procedures, and corporate standards.
Excellent communication and negotiation skills, with the ability to challenge constructively.
Proven ability to prioritize, multitask, and work independently.
Solid knowledge of GCP/ICH guidelines and applicable regulatory requirements.
Experience in adapting ICFs.
Familiarity with local regulations, SOPs, and corporate standards.
Understanding of the clinical trial environment and 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

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