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Senior Clinical Study Start-Up Specialist
2 meses atrás
At ICON Plc, we are seeking a highly skilled and experienced Senior Clinical Study Start-Up Specialist to join our team. As a key member of our clinical operations team, you will be responsible for leading regional clinical study start-up activities to ensure successful activations of investigative sites.
Key Responsibilities- Study Start-Up Management: Manage start-up activities for assigned studies at the regional level, including site identification, central and local submissions, site contracts, essential document preparation, and overall regional site activation readiness.
- Team Leadership: Ensure that clinical delivery project team members and other cross-functional team members understand their responsibilities and performance standards. Review metrics and other information sources to monitor team and individual performance.
- Communication and Risk Management: Communicate effectively with project team members to ensure alignment of study start-up strategy and risk mitigation. Identify and escalate potential risks with regional start-up activities and deliverables.
- Quality and Regulatory Compliance: Ensure quality standards and applicable regulatory requirements are met, in accordance with the protocol, applicable guidelines, and local regulations for IP release and site activations.
- Education: Bachelor's degree in a business-related, health, life sciences, or other relevant field of study.
- Experience: Broad experience and knowledge with Brazil ethical submissions (CEP/CONEP) for start-up studies. Experience in CRO, ARO, or pharma company.
- Language Skills: Read, write, and speak fluent English. Read, write, and speak Advanced Spanish.
ICON Plc is a world-leading healthcare intelligence and clinical research organization. We advance clinical research by providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. Our people are our greatest strength, and we are committed to developing our employees in a continuous learning culture.
