IQVIA
Sr/SiteActivationCoordinator
“Sr/Site Activation Coordinator at IQVIA. Skills: Site Activation, Regulatory Documents, Project Timelines. Perform tasks at a country level associated with Site Activation (SA) activities. Serve as Single Point of Contact (SPOC) in assigned studies”
Industry & Context.
Ability to work independently and to effectively prioritize tasks; Ability to manage multiple projects
What They're Looking For.
Must Have
Bachelor’s Degree in life sciences or a related field, 3 years’ clinical research or other relevant or equivalent combination of education, training and experience, 1 year experience in a leadership capacity, In-depth knowledge of clinical systems, procedures, and corporate standards, Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines, Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards, Understanding of regulated clinical trial environment and knowledge of drug development process
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
Ensure adherence to standard operating procedures (SOPs)
Perform start up and site activation activities
Distribute completed documents to sites
Prepare site regulatory documents
Review for completeness and accuracy
Ensure accurate completion and maintenance of internal systems
Review and provide feedback on site performance metrics
establish and agree on project planning
Ensure monitoring measures are in place
Implement contingency plan as needed
Inform team members of completion of regulatory and contractual documents
track and follow up the progress
Provide local expertise to SAMs
Perform quality control of documents
How You'll Work.
Team & Collaboration
Serve as Single Point of Contact (SPOC) for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments; Inform team members of completion of regulatory and contractual documents; Provide local expertise to SAMs and project team; Establish and maintain effective working relationships with coworkers, managers and clients
Communication Scope
Good negotiating and communication skills; Effective communication, organizational, 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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