RSU Specialist I, FSP Sponsor Dedicated

IQVIA Inc; United States; Remoto; USD 30.000 - 41.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work

Descrizione del lavoro

IQVIA is seeking a Regulatory & Start Up Specialist 1, cFSP for a Mexico-based, fully home-based role. The incumbent will proactively drive start-up and maintenance activities for assigned studies and sites, acting as SPOC for sites, SAMs, and project teams in alignment with SOPs and timelines.

Responsibilities include regulatory document preparation and review, tracking progress, providing local expertise, and coordinating with sponsors as needed.

Competenze

• Bachelor degree in life sciences.
• 1+ years of clinical research experience and startup management experience.
• Fluent English (written and oral).

Mansioni

• Serve as Single Point of Contact (SPOC) for sites, SAM, PM and other departments; ensure SOP/WI adherence and timelines.
• Perform startup and site activation activities per regulations, SOPs, and work instructions; distribute documents to sites and team.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems, databases and tracking tools with project data.
• Review site performance metrics and provide feedback to management.
• Establish and agree on project planning and timelines; implement contingency plans as needed.
• Inform team on completion of regulatory and contractual documents for sites.
• Track and follow up on regulatory, ethics, ICF, and IP release documents per timelines.
• Provide local regulatory expertise to SAMs and project team during planning.
• Quality control documents provided by sites.

Conoscenze

Fluent English

Analytical thinking

Interpersonal skills

Multitasking

Formazione

Bachelor's degree in life sciences

Descrizione del lavoro

Regulatory & Start Up Specialist 1, cFSP - Global Support

Mexico - 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.

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.