Clinical Operations Lead – Oncology

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

📋 Description

• Lead the local and global strategic planning, as well as the operational execution of assigned clinical studies/programs from initiation through to closure.

• Ensure the identification, initiation, and motivation of clinical study sites, focusing on patient recruitment and retention.

• Provide support to Sponsors, study sites, and vendors regarding site management and clinical monitoring tasks.

• Supervise quality control and the upkeep of studies within the CTMS and TMF.

• Organize and execute initial and ongoing project-specific training for study teams.

• Propel the successful activation of trial sites in alignment with timelines, quality/scope, and budget constraints.

• Act as the primary contact for clinical management and monitoring issues, vendors, and functional areas; escalate issues as necessary.

• Create monitoring plans and develop monitoring tools.

• Manage the preparation, execution, review, and completion of monitoring visit reports, ensuring follow-up on site-related issues.

• Conduct monitoring visits as needed.

• Collaborate with functional departments to identify clinical activity challenges and risks, and formulate mitigation strategies.

• Support the clinical operations delivery team.

• Assist with the preparation and negotiation of site contracts/budgets and payments for vendors/study sites.

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

• Develop and/or review informed consent forms and other materials provided to study participants.

• Oversee the quality of clinical deliverables and address any quality issues that arise.

• Fulfill COL II responsibilities as necessary.

⛳️ Requirements

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

• A minimum of ten (10) years of experience in clinical research trials and/or monitoring.

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

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

• Experience in oncology is essential.

• Background in Pain / CV / and Metabolic areas is a plus.

• Strong understanding of medical terminology and project financial principles.

• Adaptable and resilient, with the capacity to thrive in dynamic and challenging environments.

• Exceptional leadership abilities.

• Willingness to travel moderately, approximately 25% of the time.

• Must hold a valid driver’s license and be capable of driving to monitoring sites.

🏝️ Benefits

• Coverage for medical, dental, and vision.

• Life and AD&D insurance.

• Short- and long-term disability coverage.

• Tuition reimbursement program.

• Fitness reimbursement options.

• Employee assistance program (EAP).

• 401(k) retirement/pension plan.

• Generous paid time off and sick leave.

• Opportunity to receive a performance-based bonus.

• Accommodations available for candidates participating in recruitment and selection upon request.