Clinical Trials Manager II/III
Description
  • Oversee the delivery of large studies or programs critical to a product’s clinical development to ensure that they are completed on time, within budget and in compliance with SOPs, FDA and global regulations and ICH/GCP guidelines
  • Responsible for external vendor selection and management, and assists in the development of RFPs and vendor oversight plans
  • Provide clinical leadership to CROs, other vendors, CRA team, and CTAs
  • Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines
  • Plan, negotiate, and manage site budgets
  • Facilitate site contracting process
  • Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones
  • May manage staff and provide technical advice to team members
  • Disseminate clinical program communications to all functional groups and leads program, study and team meeting
  • Interact with clinical research investigators, Key Opinion Leaders and sites
  • Interact with Senior Management to report on progress of milestones
  • Oversight of study team and site training
  • Facilitation of Quality processes and Quality Assurance interactions for assigned project(s)
  • Management of study drug distribution and accountability processes and documentation
  • Oversight of study start-up, study management, data cleaning, and study closeout activities
  • Responsible for final study files and documentation, including TMF, final TLFs, and final study data archival
  • Provides mentorship, review, assistance or leadership for the development and writing of study protocols, study plans, CRFs, informed consent forms, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
  • Support of Clinical Operations initiatives, infrastructure, and processes (e.g. SOP development and review, financial tracking for assigned project(s), management of clinical systems, oversight of clinical metrics tracking and reporting)
  • Travel required: up to 20%
Requirements
  • BA/BS degree in Health or Life Sciences required, advanced degree preferred
  • A minimum 5 years of experience or demonstration of equivalent capability in a Clinical Trials Manager role
  • Exceptional communication and interpersonal skills
  • Advanced proficiency in Microsoft Office and Microsoft Project
  • Reliable, self-motivated, team player
  • Detail oriented with excellent organizational skills
  • Ability to effectively manage multiple tasks and competing priorities
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