Regulatory & Start Up Specialist 1 - Sponsor Dedicated

IQVIA; Ciudad de México; On-site; MXN 450,000 - 650,000; Full time

Job summary

IQVIA in Mexico City is seeking a Regulatory & Start Up Specialist 1 to manage country-level site activation activities, ensuring compliance with local and international regulations and SOPs.

You will serve as SPOC for investigative sites, activate sites, prepare regulatory documents, and maintain project systems while supporting timing and quality across the study.

This role requires strong English, analytical thinking, and the ability to handle multiple priorities in a fast-paced environment.

Qualifications

• Bachelor degree in life sciences completed.
• +1 year of clinical research experience and start-up management.
• Fluent English (written and spoken).
• Analytical and critical thinking; able to evaluate complex issues.
• Strong interpersonal skills with adaptability to changing requirements.
• Proven ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Act as SPOC for investigative sites, SAM, PM team and others; ensure SOP compliance.
• Perform start-up and site activation activities per regulations and SOPs.
• Prepare site regulatory documents for completeness and accuracy.
• Maintain internal systems and tracking tools with project data.
• Review site performance metrics and provide management feedback.
• Coordinate project planning, timelines and contingency plans.
• Inform team of regulatory and contract document completion.
• Monitor and follow up on document approvals and IP release timing.
• Provide local expertise to SAMs during planning.
• Quality control documents provided by sites.
• May contact sponsors on specific initiatives.

Skills

Fluent English

Analytical thinking

Interpersonal skills

Multiple priorities management

Clinical research experience

Study start-up management

Education

Bachelor's degree in life sciences

Job description

Regulatory & Start Up Specialist 1, cFSP

Job Overview: The RSU Specialist 1 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.

Qualifications

• Bachelor Degree in life sciences (concluded).
• +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.