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Clinical Study Manager
hace 2 meses
At ICON plc, we're committed to fostering an inclusive environment that drives innovation and excellence in clinical development. As a Site Management Associate, you'll play a critical role in managing, implementing, and monitoring clinical studies within a global organization.
Key Responsibilities:- Complete essential document collection and review throughout the study lifecycle, including site activation.
- Manage the electronic Trial Master File for each site, performing periodic QCs and site-level maintenance of the eTMF.
- Update Clinical Management Systems, local regulatory tasks, protocol amendments, submissions packages, and preparations for sites/ethics committees submissions.
- Conduct remote site monitoring visits and/or targeted on-site visits as needed.
- Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal, and progress/annual reports, site & study close-out related tasks.
- Perform study tracking CTMS.
- Act as primary site contact/liaison for study and site management issues, including addressing questions, protocol questions, managing study supplies, and conducting off-site central monitoring visits and contacts (pre-study, initiation, monitoring, and close-out visits).
- Escalate issues and risks as needed.
- Provide training and mentoring to less experienced team members.
- Act or assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management, and evaluation of metrics to identify process improvements.
- Contribute to business development activities by participating in proposals and bid defenses.
- Support manager and interface with partner departments to support enhanced project delivery. Also, may create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers.
- Bachelor's Degree, preferable in health/sciences.
- In-depth knowledge of the drug development process.
- +3 years experience in similar position.
- Knowledge about ethics committees and MOH submissions for protocols, amendments, investigator brochure, and ICFs.
- In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.
- Advanced English level (oral and written) – mandatory.
- Monitoring/remote monitoring experience (recommended for level I - mandatory for senior).
