Clinical Operations Lead I – Oncology

🔥 14 hours ago

🇨🇦 Canada – Remote

💵 $110k - $160k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Provide leadership, local/global strategic planning and operational delivery of assigned clinical studies/program through all phases of study management • Ensure effective identification, initiation and motivation of clinical study sites • Provide internal and external customer service related to site management and clinical monitoring activities • Provide oversight and quality control review for setup and maintenance of studies in CTMS and TMF • Plan and conduct initial and ongoing training for the study team • Drive successful activation of trial sites according to time, quality/scope and budget parameters • Serve as initial point of contact for clinical management and monitoring issues, vendors and other functional areas • Develop a monitoring plan and monitoring tools • Oversee preparation, conduct and timely completion of monitoring visit reports and follow-up on site issues • Conduct monitoring visits as necessary • Collaborate with functional departments to identify issues and risks and assist with mitigation plans • Assist the clinical operations delivery team • Assist with preparation and negotiation of site contracts/budgets and prepare vendor/study site payments • Assist with preparation and submission of regulatory documents to regulatory agencies, authorities, IRBs and/or Research Ethics Committees • Develop and/or review information provided to study subjects, including informed consent forms • Monitor quality of clinical deliverables and address quality issues • Perform COL II responsibilities as needed

🎯 Requirements

• Bachelor’s degree or RN in a life science or related field of study • Seven (7) years’ clinical research trial and/or monitoring experience • Thorough knowledge of ICH-GCP guidelines and applicable regulations • Demonstrated experience conducting clinical trials within the Pain therapeutic area (acute and chronic) • Oncology experience required • Pain / CV / and Metabolic experience would be advantageous • Thorough comprehension of medical terminology and project financial principles • Moderate travel may be required, approximately 25% • Must maintain a valid driver’s license and be able to drive to monitor sites • Flexible and resilient with ability to evolve in changing and challenging environment • Excellent leadership skills, promoting motivation and empowerment of others

🏖️ Benefits

• medical, dental, and vision coverage • life & AD&D insurance • short- and long-term disability • 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