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Senior Clinical Trial Manager

2 months ago

Dallas, Texas, United States Argenx Full time
Job Summary

The Senior Clinical Trial Manager will be responsible for overseeing all operational aspects of assigned clinical studies from initiation to closure. This includes managing timelines, budgets, and quality assurance to ensure successful trial execution.

Key Responsibilities
  • Lead clinical trial teams and participate in team meetings
  • Identify and mitigate risks, provide solutions, and oversee implementation
  • Oversee trial-related aspects, timelines, budget, and quality
  • Ensure trials are executed according to the Clinical Development Plan, trial plans, and applicable legislations
  • Support and participate in CRO and vendor selection
  • Lead CRO contract negotiations
  • Responsible for leading, guiding, and overseeing CROs and vendors
  • Member of the Country and Site Selection Commission
  • Develop and provide input on trial-related materials
  • Oversee patient recruitment and proactively identify ways to prevent recruitment delays
  • Develop monitoring and site oversight strategy and oversee adherence to it
  • Review monitoring visit reports, protocol deviations, and data listings
  • Monitor data quality and ensure timely availability of investigational product supply
  • Ensure timely collection, documentation, and reporting of Adverse events and Serious AEs
  • Establish and maintain supportive relationships with clinical sites and trial personnel
  • Clearly communicate goals and expectations and motivate team members
  • Proactively identify and solve issues and escalate them as needed
  • Responsible and contact person during inspections/audits
  • Identify efficiencies, best practices, and lessons learnt
Additional Responsibilities
  • Provide input to the clinical development strategy/plan
  • Provide input to procedures/SOPs/WIs and related documents
  • Participate in workstreams
  • Ensure best practices and lessons learnt are shared across trials/indications/compounds
  • Coach and mentor other team members
Requirements
  • Knowledge of ICH-GCP and other applicable legislation
  • Experience with tools and systems for managing clinical studies
Education, Experience, and Qualifications
  • Bachelor's degree or University degree - medical or para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.) or equivalent by experience
  • Minimum of 6-7 years of experience in Clinical Operations and managing CROs and vendors
  • Biotech experience is a plus
  • Auto-immune and/or oncology clinical trial background is a plus