IQVIA
life sciences
Sr.SiteActivationSpecialist(m/w/d)
“Sr. Site Activation Specialist (m/w/d) at IQVIA. Skills: Site Activation, Clinical Research, Regulatory Affairs. Perform clinical research site activation activities. Serve as Single Point of Contact”
What You'll Achieve.
Ensure adherence to quality of designated deliverables; Ensure regulatory documents and approvals are granted; Ensure specific project deliverables are completed; Ensure overall project efficiency and adherence to project timelines
Industry & Context.
What They're Looking For.
Must Have
University Degree in life science or other scientific discipline or apprenticeship in health care or as legal secretary / paralegal, Clinical research experience, preferable in study start-up, Knowledge of applicable clinical research regulatory requirements i. e. , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, Fluent language skills in German (on at least C1 level) and a good command of English, written and verbal communication skills, Attention to detail and ability to work on multiple tasks and prioritize
Nice to Have
study start-up experience
What You'll Do.
Perform clinical research site activation activities
Serve as Single Point of Contact
Ensure adherence to standard operating procedures
Start-up and Maintenance activities
prepare and negotiate site contracts and budgets
Prepare site regulatory documents
Complete and submit approval request documents
Ensure regulatory documents and approvals are granted
track and follow up the progress
Ensure accurate completion and maintenance of internal systems
establish and agree on project planning
Ensure overall project efficiency and adherence to project timelines
Ensure monitoring measures are in place
Review and provide feedback on site performance metrics
How You'll Work.
Team & Collaboration
Serve as Single Point of Contact in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Management and the client.
Communication Scope
written and verbal communication skills
Process & Methodology
Review, establish and agree on project planning and project timelines, Ensure overall project efficiency and adherence to project timelines
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