Project Manager Overview • The Project Manager role focuses on leading Phase I Oncology clinical trials remotely, ensuring operational excellence and regulatory compliance. • Coordinate cross-functional teams to deliver high-quality data and meet timelines in a fast-paced environment. • Provide oversight for Clinical Research Associates (CRAs), ensuring effective monitoring and issue resolution. • Serve as the primary operational contact for sponsors, CROs, vendors, and investigative sites. • Manage site activation, enrollment forecasting, and performance metrics to achieve study objectives. • Ensure compliance with ICH-GCP, FDA regulations, and internal SOPs across all study activities. • Drive continuous improvement initiatives to optimize operational efficiency and CRA effectiveness. • Prepare comprehensive study reports and updates for stakeholders, ensuring transparency and accountability. • Contribute to protocol development, operational feasibility assessments, and study start-up planning. Project Manager Key Responsibilities & Duties • Lead day-to-day management of Phase I Oncology trials, ensuring adherence to protocols and timelines. • Provide direct oversight of CRAs, reviewing performance and ensuring timely issue resolution. • Manage study deliverables, milestones, and risk mitigation plans effectively. • Oversee site activation, monitoring strategies, and enrollment forecasting. • Ensure compliance with regulatory standards and internal procedures throughout study activities. • Facilitate cross-functional team meetings, ensuring accountability and progress tracking. • Support budget tracking, vendor management, and invoice reconciliation tasks. • Contribute to protocol development and operational feasibility assessments. • Prepare study status reports and dashboards for sponsor-facing updates. Project Manager Job Requirements • Bachelor’s degree in life sciences or related field; advanced degree preferred. • 3–5 years of Project Management experience within clinical research, particularly Phase I Oncology. • Strong understanding of monitoring activities and CRA workflows. • Experience with eTMF, CTMS, and electronic data capture systems. • Demonstrated ability to lead cross-functional teams and manage complex timelines. • Excellent communication, problem-solving, and stakeholder-management skills. • Preferred: Experience working with CROs and external vendors. • Familiarity with oncology safety reporting and early-phase operational challenges. • Ability to work independently, manage competing priorities, and maintain high attention to detail.