Clinical Operations Lead I (Oncology)

Location: Remote, Canada, or office-based in the Greater Toronto Area

Employment type: Full-time

Travel: Approximately 25%

About the Opportunity

We are partnering with an established, growing contract research organization (CRO) to recruit a Clinical Operations Lead with oncology experience.

This opportunity offers the chance to lead clinical monitoring and site management activities for studies supporting pharmaceutical, biotechnology and medical device clients. You will join a collaborative team focused on delivering high-quality clinical research and supporting the development of new treatments.

About the Role

As Clinical Operations Lead, you will take responsibility for the clinical monitoring and site management delivery of assigned studies, from start-up through to close-out.

You will provide leadership, mentoring and technical support to clinical operations colleagues, ensuring studies meet agreed timelines, quality standards and budget commitments. You will also oversee study progress and compliance with protocols, study plans, standard operating procedures and applicable regulatory requirements.

Key Responsibilities

• Lead the planning and delivery of clinical operations activities across study start-up, conduct and close-out.
• Oversee site identification, initiation and activation, supporting patient recruitment and retention.
• Coordinate clinical monitoring and site management activities, maintaining effective relationships with sponsors, sites and vendors.
• Develop monitoring plans and study-specific monitoring tools.
• Oversee monitoring visits, review visit reports and ensure timely follow-up and resolution of site issues.
• Conduct monitoring visits when required.
• Provide oversight and quality review of study set-up and maintenance within CTMS and TMF systems.
• Deliver study-specific training, mentoring and technical guidance to clinical operations team members.
• Act as the initial contact for clinical management and monitoring queries, escalating issues where appropriate.
• Identify study risks and collaborate with cross-functional teams to develop mitigation plans.
• Monitor clinical deliverables against quality, timeline and financial targets.
• Support the preparation and negotiation of site contracts and budgets, alongside site and vendor payment activities.
• Support regulatory and ethics submissions and the development or review of informed consent documents.

About You

• Bachelor’s degree in a life science or related discipline, or a Registered Nursing qualification.
• At least seven years’ experience in clinical research and/or clinical monitoring.
• Oncology clinical trial experience is essential.
• Experience in pain, cardiovascular and/or metabolic studies would be advantageous.
• Thorough knowledge of ICH-GCP and applicable clinical research regulations.
• Strong understanding of site management, clinical monitoring and study delivery.
• Demonstrated leadership skills, with the ability to motivate, mentor and support study teams.
• Strong organizational, communication and stakeholder management skills.
• Understanding of medical terminology and project financial principles.
• Ability to adapt to evolving processes, systems and study requirements.
• Willingness to travel approximately 25%, with a valid driving license and the ability to drive to study sites.

Benefits

A comprehensive benefits package is available, including medical, dental and vision coverage, life and disability insurance, a pension plan, paid time off, sick leave, tuition and fitness reimbursement, and an employee assistance program. The role also offers eligibility for a performance-based bonus.

Should this opportunity spark some interest, please apply with a copy of your CV to set up a confidential discussion or reach out to olivia@warmanobrien.com.