Project Manager

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.