Study Start-Up Specialist - POLAND
Descripción del trabajo
Under the guidance of the EU Study Start-Up Manager of Global Clinical Study Support, this position will be responsible for conducting end-to-end site start-up from feasibility to site activation serving as the primary point of contact for the site and the study team. This includes supporting site level feasibility assessments, coordinating site identification at a country and regional level, supporting site qualification, and site start-up activities.
- Serve as primary point of contact to study team on end-to-end start up activity
- Participate in or lead Study Start-up team meetings as appropriate
- Utilize Study Start Up tools to track activities and develop reports
- Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and the collection and analysis of Feasibility Questionnaires
- Conduct site contract/budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
- Collect essential documents from sites, tracking & review led by Document Management Team
- Support the collection of country and site level intelligence
- Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
- Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate
- Support the other SSU Specialists with the collection and review of Essential Documents for sites located in other countries
- Support the local clinical operations team with other trial-related tasks
- BA/BS degree in Science or related field.
- At least 5 years’ experience in site start-up and contract management in pharmaceutical company or in clinical research organization.
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures.
- Strong presentation, documentation, and interpersonal skills.
- Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.
- Excellent oral and written communication skills.
- Proficient in English.
- Excellent planning and organizational skills with effective time management.
- Excellent interpersonal skills.
- Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- Thorough understanding of clinical research principles and process.
- Thorough understanding of FDA and/ or EU-UK Directives and regulations, ICH Guidelines and country/local regulatory requirements.
- Goal oriented, self-starter with proven ability to work independently.
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines.
- Ability to proactively identify and solve problems.
- Is flexible and willing to provide cross-functional support.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
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