Offer summary

Qualifications:

Bachelor's Degree in life sciences or a related field., 3 years of clinical research or relevant experience, or equivalent education and training., 1-3 years of experience in site activation/regulatory and startup in Brazil., Advanced level of English..

Key responsabilities:

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

Perform startup and site activation activities in compliance with regulations and SOPs.

Prepare and review site regulatory documents for accuracy and completeness.

Monitor project timelines and site performance metrics, implementing contingency plans as needed.

Job description

Job Summary:
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.

Qualifications:

• Bachelor's Degree Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
• 1-3 years clinical research experience working in the site activation / regulatory and start up department in Brazil. You will be:

Preparing Packages to Local EC and Central EC for Main site and remaining sites
Working with ICF amendments preparation (country and site specific)
Managing of eTMF
System updating
ANVISA knowledge (update FAEC information, Annual Reports, End of Study submission)

• Advanced level of English

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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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