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About the role
- Study Start Up Associate II responsible for clinical trial initiation and compliance at ICON. Collaborating with sites to ensure all necessary documentation and processes are completed smoothly.
Responsibilities
- Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
- Contribute to the advancement of innovative treatments and therapies
- Contribute to site start-up and activation activities, taking responsibility for your deliverables
- Work directly with assigned sites on all site related essential document collection and review
- Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics
- Ensure standards are applied to the SSU processes across projects
- Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
- Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned
- Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team
- Review and provide feedback to management 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.
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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