Offer summary

Qualifications:

Bachelor’s Degree in Life Science, Business Administration, Finance, or related field., Minimum of three years of relevant experience in the biopharmaceutical or CRO industry, including experience in Ethics Committee submissions in Mexico., Fluent in English, both written and oral., Proficiency with Veeva Vault and Microsoft Office applications..

Key responsibilities:

Serve as the primary contact for study sites throughout the project lifecycle.

Participate in study team meetings and provide updates on site activities.

Support regulatory submissions and site activation activities, including document collection and tracking.

Manage multiple tasks and ensure timely delivery of study-related activities.

Job description

Regulatory & Start Up Specialist, cFSP.
Location: Mexico - Full home based
Job Overview
This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification, site level regulatory green light and site maintenance/close-outs.
Essential Functions
Participate in development of in-house model process documents.
For assigned sites and countries, serve as a primary site contact for end-to-end study activity.
Participate in all assigned Study Site Management study team meetings, providing cross-functional teams with detailed updates related to study and site activity.
Utilize systems and tools to track assigned activities and produce reports and metrics as needed.
Oversee essential document collection, tracking & review.
Support the collection of country and site level intelligence
Support Ethics Committee and Regulatory Authority submissions
Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate or maintain sites for a study as appropriate.

Qualifications
Bachelor’s Degree in Life Science, Business Administration, Finance or related field or work experience equivalent.
Minimum of three years of relevant experience in the biopharmaceutical/CRO industry, including experience in EC submission in Mexico.
ICF customization experience
Fluent English: written and oral communication skills
Proficiency with Veeva Vault and all applications of Microsoft Office.
Ability to negotiate complex contract and payment terms.
Goal oriented, self-starter with proven ability to work independently.
Able to proactively identify issues and provide potential solutions for resolution.
Detail oriented.
Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
Good interpersonal skills

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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