Study Start Up Associate
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Job Description
Study Start Up Associate launching clinical trials for ICON, a global healthcare intelligence and clinical research organisation. Managing site activation, essential documents, timelines, and eTMF accuracy.
Responsibilities:
- Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
- Contribute to site start-up and activation activities
- Work directly with assigned sites on essential document collection and review
- Partner with internal Study Startup, CROs, Clinical Operations teams, and TAU partners to improve SSU metrics and processes
- Ensure standards are applied to SSU processes across projects
- Review site essential documents for start-up, including ICF, FDF, 1572, and CVs
- Recognize and improve potential site activation delays and escalate issues
- Track actions and communications with sites to achieve study and site timelines
- Support resolution of escalated issues with the internal Study Startup team
- Review and provide management feedback on site performance metrics
- Ensure accuracy and completeness of the eTMF for assigned sites during start-up
Requirements:
- BS degree or international equivalent
- 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor
- Ability to explain data to facilitate decision making processes to be data driven
- Knowledge and understanding of clinical study protocols and essential documents
- Strong organizational skills, decision making, communication and negotiation skills
- Proficient in Microsoft Excel, Word, and PowerPoint
- Legal right to work in the country where the role is based
Benefits:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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