Experteer Overview
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In this role you lead the Study Management Team within Global Clinical Development Operations to ensure global trial deliverables meet timelines. You partner across cross-functional teams, vendors, and trial sites to drive startup, execution, and close-out activities with inspection readiness in mind. You manage budgets, documentation, risk mitigation, and CAPA processes, enabling compliant, timely trials that advance sponsor programs. You will influence process improvements and lead regional/global coordination in a fast-paced, matrix environment.
Compensaciones / Beneficios
• Lead the Study Management Team across insourced and outsourced trials and provide trial status updates to the team
• Ensure availability of real-time trial status reports aligned with the trial plan and milestones
• Maintain inspection readiness through adherence to protocol, SOPs, GCP, and regulatory guidelines
• Act as primary contact for country/regional staff and internal GCDO teams
• Oversee central activities from planning to close-out in collaboration with the Global Trial Lead
• Drive issue escalation and timely resolution; own or contribute to CAPAs
• Support site selection, feasibility, and enrollment planning with data contributions
• Manage country budgets, OOPs, and vendor spend with oversight of selected vendors
• Create/update trial documents (monitoring guidelines, ICF, IMP docs, etc.) and coordinate Investigator Meetings
• Coordinate data cleaning and contribute to database lock readiness
• Ensure cross-functional input into safety, deviations, and archiving plans; prepare HA/EC/IRB submissions
• Develop training materials and deliver regional/croplet staff training as needed
• Maintain relationships with country representatives, data management, and clinical supplies units
• Demonstrate deep therapeutic knowledge and ensure compliance with QA and BRQC processes
• Lead or participate in process improvements and training initiatives
Responsabilidades xpzdshu
• BS degree or equivalent in Life Sciences
• 6-8 years of clinical trial management experience in pharma or CRO
• Strong knowledge of ICH-GCP and local regulations
• Proven leadership in directing SMTs and coordinating global/virtual teams
• Ability to manage multiple stakeholders and drive project plans
• Experience with budgeting, vendor management, and trial documents
• Proficient in English and local country language; strong communication skills
• Decision making, problem solving, and analytical abilities
• Experience with CTMS, Trial Master File, and regulatory submissions
• Willingness to travel
Requisitos principales
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