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Senior Clinical Trial Manager (Oncology, Sponsor Dedicated)
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Job Description
Job Title: Senior Clinical Trial Manager (Oncology, Sponsor Dedicated) Job Location: Boston, Massachusetts, United States of America Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Overview Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
, while serving as a subject matter expert and resource for quality and compliance standards across assigned studies. Complies with relevant training requirements and maintains advanced therapeutic, operational, and regulatory knowledge applicable to assigned programs.
Leads and contributes to quality Site Selection through participation in site feasibility ensuring consistent conduct of site qualification visits and appropriate follow-up of site qualification visit reports and country feasibility reports.
Collaborates with central study teams and local stakeholders as applicable for final selection of sites to participate in trials and provides strategic recommendations for site selection and performance optimization.
Ensures local/country team is meeting recruitment targets with high quality data on time and within study budget by providing strategic input to study-level documents and independently leading/coordinating local team activities in compliance with SOPs, other procedural documents, and applicable regulations.
This may require development of local trial-specific procedures and tools, recruitment planning, contingency and risk management, budget forecasting, and mitigation strategies for complex studies.
Acts as primary Sponsor contact for assigned trial at the country level and serves as the local operational lead for complex studies. May attend/participate in Investigator Meetings as needed and may schedule and conduct local/country investigator meetings.
Drives study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze tr
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