Regulatory and Start Up Specialist - Spain

IQVIA; Barcelona; Presencial; EUR 38.000 - 54.000; Jornada completa

Descripción de la vacante

IQVIA in Barcelona is seeking a Site Activation professional to manage country-level site activation activities in accordance with local and international regulations, SOPs, and project budgets. You will be the primary contact for investigative sites, SAM, PM teams, and other departments to ensure timely startup and regulatory compliance.

Under supervision, you will prepare and review regulatory documents, distribute completed materials, maintain project databases, and provide local expertise

Formación

• 1-year clinical research experience.

Responsabilidades

• Serve as SPOC for investigative sites, SAM, PM team and other departments.
• Ensure adherence to SOPs, WIs, quality of deliverables, and project timelines.
• Perform site start-up and activation activities per regulations and SOPs.
• Distribute documents to sites and internal teams.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems and project tracking with site data.
• Review site performance metrics and provide feedback to management.
• Plan and agree on project timelines and milestones.
• Implement monitoring measures and contingency plans as needed.

Conocimientos

SPOC coordination

Descripción del empleo

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site regulatory documents, reviewing for completeness and accuracy.
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines.
• Ensure monitoring measures are in place and implement contingency plan as needed.
• Inform team members of completion of regulatory and contractual documents for individual sites.
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives.

Qualification s

1-year clinical research experience.

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 is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.