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Company:
ICON
Location:
ES -
araba
Posted: May 11, 2025
As a Clinical Operations Lead, you will join the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
The Senior Clinical Operations Lead will support the Clinical & Medical Program Manager / operational team in executing trials. These include, but are not limited to, rollover (extension) studies, closing and terminating studies, and post-trial access programs.
What you will be doing :
- Participate in working groups and special projects to improve the efficiency, effectiveness, and quality of the Development Operations department.
- Serve as a preliminary liaison for study sites, conveying study information, answering questions, and following escalation pathways.
- Build relationships with investigational sites, healthcare professionals, and institutions to facilitate trial conduct.
- Monitor study timelines and key deliverables; manage external vendors (Monitoring, Sample Management, IVRS, Laboratory, etc.).
- Coordinate with Pharmacovigilance and safety groups as needed.
- Review data and resolve discrepancies.
- Assist in developing the Investigational Product (IP) and co-medication strategies, working closely with other departments.
- Plan and organize meetings (investigator / coordinator, DMC, SMC, safety calls).
- Help develop and manage study timelines and recruitment strategies.
- Oversee activities at investigational sites, review monitoring reports, and support monitoring teams.
- Participate in feasibility assessments of investigational sites in collaboration with the Clinical Trial Logistics group.
- Create and review Master Informed Consent Forms (ICF), updating for new risks and amendments.
You are :
- BS / BA degree or relevant science-focused degree, or equivalent experience.
- At least five years of relevant experience in the biopharmaceutical industry or clinical research.
- Knowledge of ICH Good Clinical Practices and regulatory requirements.
- Experience with multinational clinical trials is preferred.
- Ability to manage multiple priorities across various protocols and therapeutic areas.
•
Read the full job description and apply online on the recuiter's web-site
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