Clinical Study Delivery Lead

2 weeks ago

Emelle Alabama, United States Pharmaceutical Research Associates, Inc Full time
Job Summary

We are seeking a highly skilled Clinical Study Delivery Lead to join our team at Pharmaceutical Research Associates, Inc. As a key member of our clinical research organization, you will be responsible for planning and leading the delivery of interventional studies to time, quality, budget, and company standards.

Key Responsibilities
  • Accountable for the operational delivery of clinical studies to time, quality, and budget
  • Drive decision-making at pace and lead study teams to achieve overall study deliverables
  • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and SOPs for assigned studies
  • Proactively and effectively identify, oversee, and mitigate study risks
  • Ensure appropriate stakeholder communication, including study status, expectations, risks, and issues
  • Prepare materials for governance and/or financial review cycles
  • Accountable for the study budget
  • Effectively build and lead empowered matrix teams
  • Implement innovative approaches to study delivery through external facing advances in technology and sciences
  • Decision maker for innovative solutions to be used at study level
  • Responsible for operational input into protocol and informed consent form development, and other key study documents
  • Lead and conduct investigator meetings and other study-related meetings; participate in governance meetings as required
  • Lead quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies
  • Ensure data quality plans and end-to-end data cleaning is performed instream by the responsible line functions
  • Ensure Clinical Study Report is delivered on time and supports adherence to local regulatory guidance
  • Identify and communicate resource gaps for assigned studies
  • Lead/contribute to ways of working and process improvement initiatives
Requirements
  • Bachelor's degree in life sciences or related discipline
  • Experience in clinical research: study management, monitoring, data management
  • Strong skills and experience in project management and tools
  • In-depth knowledge of GCPs and ICH guidelines
  • Solid experience working in teams with a broad range of cultures, including matrix team leadership
  • Excellent leadership skills, promoting motivation and empowerment of others
  • Excellent understanding of the clinical study, drug development, sample management, and other associated process and quality requirements
  • Good project management skills, including scope, budget, timeline, and resource planning and management
  • Able to lead and work within teams and networks across functional and geographical boundaries
  • Able to set and manage priorities, performance targets, and project initiatives in a global environment
  • Operational expertise in risk management and contingency planning
  • Applies industry best practices to the design and execution of clinical studies to improve time and cost efficiency
  • Demonstrates conceptual, analytical, and strategic thinking
  • Effective at problem-solving and conflict resolution
  • Ability to manage change and uncertainty
  • Ability to delegate tasks
What We Offer

We offer a competitive salary and a range of benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a global employee assistance program.

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