Associate Clinical Study Start-Up Manager
Lifelancer
Lead clinical site activation from home in Quebec with IQVIA Biotech, applying regulatory strategy, study start-up, and project management expertise.As an Associate Study Start-Up Manager, you will manage activation, maintenance, and regulatory activities for assigned studies or multi-protocol programs. The position covers scope, budgets, resources, timelines, and collaboration across Regulatory and Site Activation. You will support business development, study initiation, ongoing approvals, and clinical trial compliance.Key Responsibilities:
Oversee site activation and maintenance for assigned projectsDevelop management plans aligned with scope and strategyDetermine regulatory strategies and submission expectationsMaintain CTMS, databases, timelines, and project plansMentor colleagues and deliver presentations or trainingRequirements:
Bachelor's degree in life sciences or related fieldSeven years' relevant scientific or clinical experienceInternational experience in a scientific or clinical environmentKnowledge of GCP, ICH, and applicable regulatory guidelinesStrong negotiation, communication, leadership, and planning skillsApply clinical trial oversight, regulatory expertise, and study start-up leadership to complex programs with IQVIA Biotech.
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Oversee site activation and maintenance for assigned projectsDevelop management plans aligned with scope and strategyDetermine regulatory strategies and submission expectationsMaintain CTMS, databases, timelines, and project plansMentor colleagues and deliver presentations or trainingRequirements:
Bachelor's degree in life sciences or related fieldSeven years' relevant scientific or clinical experienceInternational experience in a scientific or clinical environmentKnowledge of GCP, ICH, and applicable regulatory guidelinesStrong negotiation, communication, leadership, and planning skillsApply clinical trial oversight, regulatory expertise, and study start-up leadership to complex programs with IQVIA Biotech.
#J-18808-Ljbffr
Vacancy posted 1 hour ago
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