Offer summary

Qualifications:

Bachelor's Degree in life sciences, Over 1 year of clinical research and study start-up management experience, Fluent in English with strong written and oral communication skills, Good analytical, critical thinking, and interpersonal skills..

Key responsibilities:

Serve as the Single Point of Contact (SPOC) for investigative sites and project teams.

Perform start-up and site activation activities in compliance with regulations and SOPs.

Prepare and review site regulatory documents for accuracy and completeness.

Monitor project timelines and ensure the completion of regulatory and contractual documents.

Job description

Regulatory & Start Up Specialist, Sponsor Dedicated - 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

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