Clinical Operations Lead I – Oncology

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead the strategic planning and operational execution of assigned clinical studies/programs throughout all phases of study management.

• Ensure the effective identification, initiation, and motivation of clinical study sites.

• Deliver exceptional internal and external customer service related to site management and clinical monitoring activities.

• Provide oversight and quality control review for the setup and maintenance of studies in CTMS and TMF.

• Plan and conduct both initial and ongoing training for the study team.

• Ensure successful activation of trial sites in accordance with time, quality/scope, and budget parameters.

• Act as the primary point of contact for clinical management and monitoring issues, vendors, and other functional areas.

• Develop a comprehensive monitoring plan and monitoring tools.

• Oversee the preparation, execution, and timely completion of monitoring visit reports, and follow up on site-related issues.

• Conduct monitoring visits as necessary.

• Collaborate with functional departments to identify issues and risks, assisting with mitigation plans.

• Support the clinical operations delivery team.

• Assist in the preparation and negotiation of site contracts/budgets, and manage vendor/study site payments.

• Aid in the preparation and submission of regulatory documents to regulatory bodies, authorities, IRBs, and/or Research Ethics Committees.

• Develop and/or review information provided to study participants, including informed consent forms.

• Monitor the quality of clinical deliverables and address any quality issues.

• Perform COL II responsibilities as needed.

⛳️ Requirements

• Bachelor’s degree or RN in a life science or a related field of study.

• Seven (7) years of experience in clinical research trials and/or monitoring.

• Comprehensive knowledge of ICH-GCP guidelines and applicable regulations.

• Proven experience conducting clinical trials within the Pain therapeutic area (both acute and chronic).

• Oncology experience is mandatory.

• Experience in Pain/CV/and Metabolic areas would be beneficial.

• Strong understanding of medical terminology and project financial principles.

• Moderate travel may be necessary, approximately 25%.

• Must possess a valid driver’s license and be able to drive to monitoring sites.

• Must be flexible and resilient, with the capability to adapt in a changing and challenging environment.

• Excellent leadership skills with a focus on motivating and empowering others.

🏝️ Benefits

• Medical, dental, and vision coverage.

• Life & AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement.

• Fitness reimbursement.

• Employee assistance program (EAP).

• A pension plan.

• Generous paid time off and sick leave.

• Opportunity to earn a performance-based bonus.