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Clinical Trial Manager
Posted on 7/6/2022
INACTIVE
Locations
Everett, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Management
Writing
Requirements
  • BS/BA degree or equivalent and minimum of 5 years' experience in clinical operations
  • Strong understanding of FDA and ICH GCP guideline to ensure the appropriate conduct of clinical studies
  • Confidence and excellent communication, writing, and presentation skills
  • The ability to multitask and quickly pivot, while keeping significant attention to detail
  • Passion to drive study deliverables to meet aggressive timelines
Responsibilities
  • Manage, lead, and execute assigned clinical trials(s). You will work closely with cross functional department leads and be responsible for ensuring trials are executed smoothly and completed on time, within budget, and in compliance with GCP
  • Play a key role in the selection and oversight of CROs and other clinical vendors
  • Represent clinical operations on the program team, providing overall status updates, issue escalation and present risk management strategies to the cross-functional team
  • Participate in authoring study documents including protocols, investigator brochure, informed consent form, and other study related manuals and materials (pharmacy/lab manual, dosing diaries, etc.)
  • Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
  • Ensure execution of activities outlined in various study plans, including communication plans, data management plans, and safety management plans
  • Perform quality assurance checks (e.g. conducting co-monitoring visits at clinical sites as needed) and drive quality efforts to proactively identify and manage risks to ensure inspection readiness
  • Partner with CMC to oversee drug supply for assigned clinical trials, including participating in long term supply planning
  • Take accountability for the management of assigned clinical study budgets through review of study-level scopes of work, invoices, and change orders in accordance with the evolving needs of the study
  • Work closely with Investigators, clinical site staff and all CROs and vendors to build and develop effective relationships
Valo Health

51-200 employees

AI-powered drug discovery & development
Company Overview
Valo is a mission-driven technology company that was created with the belief that the drug discovery and development process can and should be better—faster, less expensive, and with a higher probability of success.