Project Manager – Oncology Clinical Trials

About the role

The Project Manager will lead the planning, execution, and monitoring of multiple oncology clinical trials and research projects. Reporting to the Projects Director, the role ensures that studies are conducted ethically, safely, and with high data integrity while meeting budget and timeline targets.

Key responsibilities

• Develop and maintain comprehensive project plans, schedules, and budgets for each trial.
• Oversee trial set‑up, execution, and close‑out, ensuring deliverables meet quality standards.
• Manage internal and external stakeholder communication, including partners, vendors, and study coordinators.
• Lead and coordinate the project team, securing appropriate staffing with department heads.
• Ensure compliance with ICH GCP E6(R3) and internal policies, maintaining accurate documentation in CTMS and eTMF.
• Prepare for audits and inspections, supporting regulatory compliance.
• Integrate risk‑based quality management and Quality‑by‑Design principles throughout the project lifecycle.
• Facilitate change management, risk identification, assessment, and mitigation.
• Provide mentorship and guidance to new team members.

Required profile

• Proven experience managing clinical trials or research projects in oncology.
• Strong understanding of ICH GCP guidelines and regulatory requirements.
• Excellent organizational, communication, and stakeholder‑management skills.
• Ability to lead cross‑functional teams and drive project timelines.
• Experience preparing for audits, inspections, and regulatory submissions.

Required skills

• Clinical Trial Management System (CTMS) proficiency
• Electronic Trial Master File (eTMF) management
• ICH GCP E6(R3) knowledge
• Risk Management and Quality‑by‑Design methodologies