IQVIA
StudyStartUpManager(SSUM)Greece
“Study Start Up Manager (SSUM) Greece at IQVIA. Skills: site activation, regulatory activities, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs. Oversee the execution of Site Activation and/or Maintenance for assigned projects”
What You'll Achieve.
Direct and manage the delivery of all required site activation, maintenance and regulatory activities; successfully deliver the agreed project scope in compliance with the RSU Management Plan; enable study initiation and maintenance; facilitate efficient business development, initiation and maintenance of clinical trials; enable compliance with regulatory requirements; support the bid process and subsequent execution of the site activation plan; support assigned studies and wider company, as required; ensure appropriate quality standards for the duration of site activation
Industry & Context.
resolving project related issues where required; Identify regulatory complexity and challenges and offer creative and practical solutions
What They're Looking For.
Must Have
7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role, Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process, Demonstrated proficiency in using systems and technology to achieve work objectives, Good regulatory and/or technical writing skills, knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
What You'll Do.
Direct and manage the delivery of all required site activation
maintenance and regulatory activities for selected studies or multi-protocol programs
Oversee the execution of Site Activation and/or Maintenance for assigned projects
implement and maintain the Management Plan
Ensure collaboration across Regulatory & Site Activation
Create and/or review technical and administrative documentation
Provide specialist regulatory and technical scientific support
Provide overall guidance and oversight of multi-regional and multi-protocol programs
Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
Identify regulatory complexity and challenges and offer creative and practical solutions
Assess and review the regulatory landscape and contribute to the collection
analysis and dissemination of accurate regulatory intelligence
Execute operational strategy/ expectations for maintenance of clinical study approvals
authorizations and review/ negotiation of contracts and essential documents
Work with Quality Management to ensure appropriate quality standards
Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS)
timelines and project plans
How You'll Work.
Team & Collaboration
Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries; Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team; May take a lead role in developing long standing relationships with preferred IQVIA customers; Deliver presentations/training to clients, colleagues and professional bodies
Communication Scope
communication with regions and countries; regulatory and technical writing skills; Deliver presentations/training
Process & Methodology
process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, Management Plan development and implementation, project timelines adherence, project related issue resolution, project scope management
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