Clinical Trial Manager

Overview

Manage all aspects of one or more oncology Phase 1 - 4 clinical trials, from protocol development to final report, including trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.

Responsibilities

• Lead clinical trial project execution for oncology programs to ensure that trial timelines, costs, and quality metrics are met.
• Develop, manage, and oversee clinical trial timelines for the conduct of the clinical trial protocol.
• Lead role as primary contact for cross-functional area representatives in managing protocol execution.
• Manage risk including prioritization of competing tasks and issues to ensure program objectives are successfully accomplished in a timely manner.
• Manage the oversight of critically assessing data integrity to find trends/outliers and timely correct identified issues.
• Coordinate and oversee, with Clinical Contracts/Budget management, the financial aspect of of clinical trials to ensure accuracy and timeliness of service provider and site payments.
• Forecast and oversee all clinical supplies, study drug, lab supplies and other required materials.
• Manage study milestones to ensure accurate tracking and reporting of study matters.
• Oversee ongoing service provider management (e.g., CROs, IVRS, central labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
• Collaborate with Clinical Contracts/Budget to manage efforts for clinical service provider selection.
• Manage, guide and mentor to CRAs and CTAs.
• Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance and in adherence to SOPs, ICH/GCP, and local regulations.
• Lead and/or participate in ongoing process improvement initiatives.
• Supports the organization in maintaining a work environment focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
• Perform other duties as assigned or required.

Qualifications

• Minimum of 3 years' staff management experience.
• Bachelor's degree with at least 5+ years of oncology CRA experience for the manager level..
• Broad and current knowledge of regulations, clinical development process, and oncology.
• Proven leadership skills to direct protocol execution to ensure timeline, budget, and quality metrics are met.
• Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
• Experience developing trial plans, including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
• Excellent organizational and negotiation skills. Proven ability in creative problem-solving; possess sound judgment.
• Team oriented - collaborate effectively with the Clinical Operations study team, cross-functional team members, and external partners.
• Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook.
• Working knowledge of MS Project for development and update of clinical study timelines.
• The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment, and will need to occasionally move about the office for meetings and to access files and other office equipment.
• Willing to travel up to 25%.

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