Sr. CTM
Responsibilities
· Manages Clinical Operations trial activities for at least one clinical trial
· Responsible for overall study project management of a clinical trial(s) including:
o Projection and management of study timelines
o Creation and management of clinical trial budgets
o Ensures timely reporting of study metrics to Day One line and/or executive management
o For outsourced studies, manages the CRO and any supportive vendors
· Leads Day One cross-functional study management teams (SMT); is responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of meeting minutes
· Provides input on study-related meetings, including vendor selection, project kick-off, CRO project meetings, functional area-specific meetings, and Investigator meetings
· Ensures investigators and site coordinators are appropriately trained for the study, and that documentation in this regard is collected and filed
· Ensures proper training of the CRO and supporting vendors on the protocol
· Reviews and approves site monitoring visit reports in accordance with the study Monitoring Plan; escalates risk findings according to the Study Plan or Issue Escalation Plan
· Monitors CRO performance using standard Key Performance Indicators (KPI) to ensure compliance to Scope of Work; tracks KPIs for site GCP/study compliance and develops corrective action plans as required
· Active participant in selection and initiation of site
· Provides input for definition of new or revised process development, problem solving, training, etc., as needed
· May lead Clinical Operations-specific process improvement or Clinical projects
· Mentors and manages junior Clinical Operations staff, as applicable
· May attend qualification, initiation, interim monitoring, and close-out visits.
· Occasional domestic US travel up to 25%, and internationally (on an "as needed basis") in support of trial activities
· Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices
Qualifications
· BS/BA degree in related discipline; or, Advanced degree in related discipline
· Typically requires a minimum of six (6) years of related experience, contingent on education/training
· Minimum three (3) years' experience in study management is preferred, or equivalent experience gathered in a previous clinical trials management role
· Oncology experience is required
· Experience as a Clinical Research Associate is preferred
· Direct CRO management is preferred
· Extensive clinical operations knowledge and cross-functional understanding of clinical trial methodology
· Exhibits ability to learn and apply foreign regulations to the clinical trial/research process
· Experience developing trial plans (eg., site monitoring, communication, and issue escalation)
· Knowledgeable in CRF design, interactive response technology (IRT) systems, and clinical supply logistics
· Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States and internationally
· Organizes and prioritizes numerous tasks and completes them under time constraints
· Frequently applies strong analytical, organizational, and communication skills
· Working knowledge of MS Office and MS Project
· Detail-oriented
· Ability to work either independently or in a team environment
· Works on assigned problems of complex scope where analysis of situation or multiple factors is required
· Exercises judgment within defined procedures and practices to determine appropriate action
· Builds productive internal and external working relationships
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