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Senior Clinical Trial Manager

  • Location: San Francisco
  • $ Salary: US$160000.00 - US$175000.00 per annum + Healthcare benefits, 401K, Bonus per year
  • Job Type:Permanent

Posted 19 days ago



· 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


· 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