Clinical Operations Lead – Oncology

🔥 15 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $135k - $160k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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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/programs through study start-up, conduct/maintenance, and closure • Ensure identification, initiation, and motivation of clinical study sites, including patient recruitment and retention • Support Sponsors, study sites, and vendors on site management and clinical monitoring activities • Oversee quality control and maintenance of studies in CTMS and TMF • Plan and conduct initial and ongoing project-specific training for study teams • 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 functional areas; escalate as required • Develop monitoring plans and monitoring tools • Oversee preparation, conduct, review, and completion of monitoring visit reports and follow-up on site issues • Conduct monitoring visits as necessary • Collaborate with functional departments to identify clinical activity issues and risks and develop mitigation plans • Assist the clinical operations delivery team • Assist with preparation and negotiation of site contracts/budgets and 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 informed consent forms and other information provided to study subjects • 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 • Ten (10) 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 advantageous • Thorough comprehension of medical terminology and project financial principles • Flexible and resilient, with ability to evolve in changing and challenging environments • Excellent leadership skills • Moderate travel may be required, approximately 25% • Must maintain a valid driver’s license and be able to drive to monitor sites

🏖️ Benefits

• Medical, dental, and vision coverage • Life and AD&D insurance • Short- and long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program (EAP) • 401(k) retirement / pension plan • Generous paid time off and sick leave • Opportunity to earn a performance-based bonus • Accommodations for candidates participating in recruitment and selection, upon request