Regulatory & Start Up Specialist 1 - Sponsor Dedicated

IQVIA; Ciudad de México; On-site; MXN 350,000 - 450,000; Full time

Job summary

IQVIA is seeking a Regulatory & Start Up Specialist 1, cFSP, to manage country-level Site Activation activities and regulatory document preparation. You will work with the SAM, PM team, and sites to ensure compliance with SOPs, timelines, and quality standards.

The role requires a life sciences background, startup and clinical research experience, and fluent English. Strong analytical skills and the ability to manage multiple priorities in a fast-paced environment are essential.

Qualifications

• Bachelor degree in life sciences.
• +1 year of clinical research experience and startup management.
• Fluent English (written and spoken).
• Strong analytical and critical thinking.
• Excellent interpersonal and communication skills.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Serve as Single Point of Contact (SPOC) for investigative sites, SAM, PM team, and other departments.
• Perform startup and site activation activities per regulations and SOPs; distribute docs to sites and team.
• Prepare site regulatory documents, review for completeness and accuracy.
• Maintain internal systems, databases, and tracking tools with project data.
• Review and provide feedback on site performance metrics.
• Establish and agree on project timelines; ensure monitoring measures and contingency plans.
• Inform team of regulatory/contractual document completion.
• Track and follow up on approval and execution of regulatory docs per timelines.
• Provide local regulatory expertise during project planning.
• Quality control documents provided by sites.
• May contact sponsors on specific initiatives.

Skills

Life sciences background

Fluent English

Analytical thinking

Interpersonal skills

Multitasking

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.