Reg & Start Up Spec 1

IQVIA Argentina; Santiago; A distancia; CLP 12.000.000 - 18.000.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Regulatory & Start Up Specialist 1 to support Chile in a fully remote role. The incumbent will drive start-up activities, coordinate with sites and project teams, and ensure regulatory documents are accurate and complete.

Strong English communication and analytical ability are essential for success. Responsibilities include maintaining systems, tracking timelines, and providing local regulatory expertise during planning and execution.

Formación

• Bachelor degree in life sciences.
• 1+ years of clinical research experience and start-up management.
• Fluent English (written and oral).
• Strong analytical and critical thinking to evaluate complex issues.
• Strong interpersonal skills and adaptability to changing requirements.

Responsabilidades

• Serve as SPOC for sites, SAM, PM, and other departments while upholding SOPs and timelines.
• Perform start up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents and ensure completeness.
• Maintain internal systems and tracking tools with project data.
• Review and provide feedback on site performance metrics.
• Plan project timelines and monitor contingencies.
• Inform team on completion of regulatory and contractual documents.
• Provide local regulatory expertise to SAMs and project team.
• QC documents provided by sites.
• May have direct contact with sponsors on initiatives.

Conocimientos

Fluent English

Analytical thinking

Interpersonal skills

Prioritization

Educación

Bachelor in life sciences

Descripción del empleo

Regulatory & Start Up Specialist 1, cFSP - Chile support

Full Home Based role

Purpose

The RSU Specialist 1 proactively drives and executes start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country (Chile).

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.

Qualifications

• Bachelor Degree in life sciences.
• +1 years of clinical research experience and study start up management experience.
• Fluent English: written and oral communication skills
• Good analytical and critical thinking skills and the ability to evaluate complex issues from multiple perspectives
• Good interpersonal skills with the ability to build trust and communicate with clarity, flexibility and adaptability to changing requirements
• Demonstration of successful execution, preferably in start up, and aptitude for managing multiple priorities in a fast-paced environment

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.