Vacancy Description
Study Maintenance Lead
LATAM - Home-based
Job Overview
The Maintenance Lead is responsible for leading the strategic, operational, and financial delivery of clinical study maintenance activities, ensuring the timely implementation of revised clinical study documents, regulatory submissions, approvals, and associated site maintenance activities. This role provides project leadership, stakeholder management, and regulatory oversight to ensure studies remain compliant, on schedule, and aligned with sponsor and company requirements.
Key Responsibilities
Lead the execution of lifecycle maintenance activities for assigned clinical studies, ensuring compliance with ICH-GCP, regulatory requirements, sponsor expectations, and company policies.
Develop and implement maintenance strategies, plans, timelines, and deliverables to support efficient study execution.
Provide project oversight for amendments, r...
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