IQVIA
SiteActivationSpecialist
“Site Activation Specialist at IQVIA. Skills: Site Activation, Regulatory activities, Project timelines, Site performance metrics. Perform tasks at a country level associated with Site Activation (SA) activities. Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments”
What You'll Achieve.
Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines; Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information; Ensure monitoring measures are in place and implement contingency plan as needed; 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
What They're Looking For.
Must Have
2+ years of clinical research experience, Experience in clinical research regulatory activities in Argentina, Good command of English Language
Nice to Have
clinical trial assistant experience is a plus
What You'll Do.
Perform tasks at a country level associated with Site Activation (SA) activities
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites
Site Activation Manager (SAM)
Project Management team
and other departments
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
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
track and follow up the progress
the approval and execution of documents
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
How You'll Work.
Team & Collaboration
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; Inform team members of completion of regulatory and contractual documents for individual sites; Provide local expertise to SAMs and project team
Communication Scope
Excellent communication and interpersonal skills
Process & Methodology
Review, establish and agree on project planning and project timelines, Ensure monitoring measures are in place and implement contingency plan as needed
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