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Study Start Up Associate I/II/SR
hace 4 meses
At ICON, our team makes us stand out. Our diverse teams help us to be a better partner to our customers and work towards advancing and enhancing patients' lives.
Our culture is driven by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the top Clinical Research Organization that delivers excellence to our clients and patients in every interaction, striving to be the preferred partner in drug development.
This is our vision, the driving force behind our work. And we are looking for talented individuals who resonate with this vision.
If you have the same drive as us, come join our team. You'll be part of a vibrant and supportive environment with some of the brightest and friendliest faces in the industry, contributing to shaping the sector.
The Role:As a member of the Study Start Up Team, you will play a crucial role in ensuring that physicians at our research sites are ready to commence clinical trials for investigational pharmaceutical and biological products.
What you will be responsible for:- Provide country-specific expertise in Study Start Up (SSU) to SSU team leads and project teams.
- Prepare and coordinate submissions to regulatory authorities, ethics committees, and relevant bodies.
- Conduct feasibility assessments, site identification, site contract negotiations, and other SSU activities.
- Develop, finalize, and review Master and Country-Specific Subject Information Sheets/Informed Consent Forms.
- Prepare Ethics Committee (EC) and regulatory submission packages as per country requirements.
- Coordinate the completion of the Critical Document Package (CDP) and the IP release checklist in alignment with regulatory guidelines and sponsor requirements.
- Ensure processes prioritize quality, efficiency, and cost-effectiveness under guidance.
- A Bachelor's Degree or equivalent in a Medical/scientific discipline.
- 1-3+ years of experience in clinical study start-up activities.
- Proficiency in project management.
- Fluency in local language and English.
Please submit Resume/CV in English.
Benefits of Working at ICON:Our success hinges on our exceptional talent. Hence, we have built a culture that recognizes high performance and fosters talent growth.
We offer competitive salary packages, regularly benchmarked against industry standards. Bonuses are tied to performance goals, ensuring rewards for achievements.
In addition to competitive salaries, we provide a range of health-related benefits for employees and their families, offer retirement plans, life assurance, fostering long-term financial security.
But beyond the tangible benefits, you'll thrive in an environment that supports your purpose and drives positive change.
ICON values diversity and is dedicated to maintaining a workplace free of discrimination and harassment. All qualified candidates will be considered for employment regardless of background.
If you require accommodations for any part of the application process due to a medical condition or disability, please inform us.
