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[RESPONSIBILITIES]1. Study Management & Leadership- Lead and manage global clinical trials involving radiopharmaceutical and/or imaging-based studies- Oversee study timelines, budget, quality, enrollment, and operational execution- Lead study start-up, feasibility assessment, site selection, and study management activities- Ensure compliance with protocol requirements, GCP, SAE reporting, and regulatory processes- Collaborate with investigators, study sites, CROs, and global cross-functional teams- Identify, escalate, and mitigate study risks, operational issues, and quality concerns2. CRO, 3rd Party Vendor Management and Oversight / Budget- Lead CRO and vendor selection, oversight, and performance management- Manage vendors supporting radiopharmaceutical manufacturing, imaging services, and logistics- Monitor study timelines, enrollment, operational metrics, and vendor deliverables- Support clinical supply planning, forecasting, and study budget management- Review study invoices, change orders, and financial forecasts- Coordinate investigator meetings, study trainings, and vendor-related activities
[RESPONSIBILITIES]1. Study Management & Leadership- Lead and manage global clinical trials involving radiopharmaceutical and/or imaging-based studies- Oversee study timelines, budget, quality, enrollment, and operational execution- Lead study start-up, feasibility assessment, site selection, and study management activities- Ensure compliance with protocol requirements, GCP, SAE reporting, and regulatory processes- Collaborate with investigators, study sites, CROs, and global cross-functional teams- Identify, escalate, and mitigate study risks, operational issues, and quality concerns2. CRO, 3rd Party Vendor Management and Oversight / Budget- Lead CRO and vendor selection, oversight, and performance management- Manage vendors supporting radiopharmaceutical manufacturing, imaging services, and logistics- Monitor study timelines, enrollment, operational metrics, and vendor deliverables- Support clinical supply planning, forecasting, and study budget management- Review study invoices, change orders, and financial forecasts- Coordinate investigator meetings, study trainings, and vendor-related activities
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