Clinical Trial Manager

Overview

• Lead clinical trial operational strategy and oversee day-to-day study operations in a remote setting.
• Collaborate with cross-functional teams to ensure adherence to timelines, budgets, and regulatory standards.
• Manage outsourced CRO and vendor activities to maintain quality and compliance.
• Contribute to clinical document development, including protocols and regulatory submissions.
• Support study feasibility, site selection, and regulatory package preparation.
• Ensure electronic Trial Master File (eTMF) is maintained throughout the trial lifecycle.
• Provide mentorship and guidance to junior team members.
• Participate in quality assurance and regulatory inspections as needed.
• Drive process improvements and knowledge sharing within the department.

Key Responsibilities & Duties

• Lead efforts in study start-up, including feasibility and site selection.
• Manage vendor relationships and ensure adherence to quality standards.
• Organize and chair trial sub-teams, reporting progress and resolutions.
• Define and oversee data review plans to ensure scientific excellence.
• Develop and manage trial-level budgets, forecasts, and annual reviews.
• Support logistics for trial advisory committees and regulatory inspections.
• Ensure successful delivery of study lifecycle deliverables.
• Provide mentorship to Associate CTMs and CTAs.
• Collaborate with departments to meet study timelines and goals.

Job Requirements

• Bachelor's degree in a scientific discipline required; advanced degree preferred.
• Minimum 5 years of clinical research experience, with 7 years preferred.
• Strong oncology experience and understanding of clinical development phases.
• Proficiency in ICH/GCP, FDA-CFR, and regulatory compliance.
• Ability to manage multiple studies with minimal supervision.
• Excellent communication and leadership skills.
• Experience with vendor management and clinical outsourcing specifications.
• Knowledge of electronic Trial Master File (eTMF) management.
• Commitment to process improvement and operational excellence.