Study Start-Up Specialist
hace 3 días
At ICON, we're a global leader in clinical research, and we're looking for talented individuals to join our team as a Study Start-Up Associate. This role is an exciting opportunity to work with us on the front line of medical innovation.
About the RoleWe are seeking a highly skilled Study Start-Up Associate to lead regional clinical study start-up activities. In this role, you will be responsible for ensuring successful activations of investigative sites in accordance with protocol, budget, standard operating procedures, policies, and applicable regulations.
You will be part of a dynamic and innovative team that prides itself on being one of the world's leading independent biotechnology companies. Our focus is on areas with unmet medical need, and we aim to reduce the social and economic burden of disease in society today.
Your Key Responsibilities- Manage start-up activities for assigned studies at the regional level, including supporting site identification, central and local submissions, site contracts, essential document preparation, Investigational Product (IP) release, site initiation visits (SIVs) readiness, and overall regional site activation readiness.
- Ensure that clinical delivery project team members and any other cross-functional team members needed to support regional site activations understand their responsibilities and performance standards.
- Communicate effectively with project team members to ensure alignment of study start-up strategy and risk mitigation.
- Evaluate quality standards and applicable regulatory requirements to ensure compliance with the protocol, applicable guidelines, and local regulations for IP release and site activations.
- Monitor regional resource allocations for study start-up team members and consult with study start-up project leaders as needed.
- Identify and escalate potential risks with the regional start-up activities and deliverables, inclusive of proactive mitigation planning.
We offer a competitive salary range of $65,000 - $90,000 per annum, depending on experience and qualifications. In addition to your salary, we also provide a range of benefits, including:
- A comprehensive health insurance package.
- A 401(k) retirement savings plan.
- Generous paid time off and holidays.
- Opportunities for professional development and growth.
- Bachelor's degree in a business-related, health, life sciences, or other relevant field of study.
- Broad experience and knowledge with Chile ethical submissions for start-up studies.
- Experience in CRO, ARO, or pharma company.
- Fluent English language skills; fluency in host country language is preferred.
ICON is a global leader in clinical research, dedicated to helping improve human health. We are committed to providing a workplace free of discrimination and harassment and are proud to be an equal opportunity employer.
If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity. Please note that all qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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