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.
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.
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.