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 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.
- 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
IQVIA Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.
-
Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
-
Retirement Support — Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
-
Leave & Time Off Breadth — Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.
IQVIA Insights
Similar Jobs
What We Do
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.
