Associate Director, Clinical Project Management

Job Title
Associate Director, Clinical Project Management
Job ID
Work Hybrid
Hybrid, Based in UK, 
Other Location
The Associate Director Clinical Project Management Rest of World (ROW) is an expert in clinical operations and project management and is responsible for oversight and management of AGTC-sponsored clinical trials, including leading teams to deliver high priority projects on time with high quality.

Reporting Relationship
  • The Associate Director Clinical Project Management ROW will report directly to the Executive Director of Clinical Operations or designee
Duties and Responsibilities
  • Lead cross-functional teams to drive the delivery of high priority projects/programs
  • Manage all aspects of clinical trial(s)/program from study start-up through study close-out
  • Assess operational feasibility and develop/implement the study execution plan  
  • Develop and manage comprehensive study timelines and metrics
  • Lead and/or contribute to the development and implementation of vendor oversight plans to effectively manage and assess vendor performance to ensure high-quality deliverables
  • Plan, execute and lead study-specific meetings
  • Identify and implement opportunities to optimize/enhance processes and/or systems to accelerate projects/programs
  • Proactively identify risks to study timelines and budgets and implement risk mitigation strategies/solutions
  • Ensure clinical trials are executed in compliance with national/international GCP guidelines/regulations and SOPs
  • Oversee development of study related documents, including, but not limited to, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Statistical Analysis Plans (SAPs), etc.
  • Provide regular status reports to management as appropriate
  • Ensure studies are conducted in accordance with applicable regulations, GCP guidelines, protocol and affiliated documents and operational strategy
  • Participate in the planning of Quality Assurance activities and oversee resolution of audit findings
  • Ensure audit-ready condition of Clinical Trial Master Files
  • Provide routine status reports and updates to senior management committee
  • Participate in the development of SOPs and clinical operational systems
  • Work with manager to develop and achieve corporate goals within expected timeframe, ensure goals are set and communicated to direct reports
  • Manage and mentor direct reports
  • Other duties as assigned
  • This job description is subject to change at any time
Educational Qualifications
  • Bachelor’s degree
  • Bachelor’s degree in a scientific discipline preferred
Additional Qualifications
  • Six (6) years’ experience in Pharmaceutical, Biotech or CRO company, including experience with all aspects of trial and site startup and vendor management preferred
  • In-depth knowledge of all aspects of drug development across Phases 1-IV, including GCP, ICH and FDA regulations
  • Self-motivated, flexible, and independent thinker
  • Ability to work in a fast-paced/demanding environment
  • Problem solver, ability to prioritize and/or multi-task
  • Collaborative team member
  • Ability to work independently and as part of a team in a fast-paced environment
  • Ability to juggle multiple competing tasks and demands
  • Proficient in use of Microsoft products (Word, Power Point, Excel, Project)
  • Excellent oral and written communication skills
  • Strong interpersonal skill set necessary to create and maintain internal and external collaborator relationships, including vendors, CROs, etc.
  • Strong attention to detail
  • Demonstrated ability to lead, motivate and mentor staff and teams
  • Excellent written and oral communication skills
Physical Requirements
  • Physical demands: (check one)
sedentary (< 10 lbs.) light work (< 20 lbs.) medium work (< 50 lbs.)
heavy work (< 100 lbs.) very heavy work (> 100 lbs.)  
  • Physical activity: (check all that apply)
repetitive motion balancing stooping lifting climbing
kneeling/crouching crawling reaching standing  
typing/grasping walking pushing/pulling hearing  
  • Visual acuity: reading, writing preparing/analyzing data
  • Working conditions: indoor office environment
Supervisor Responsibilities
Previous management or supervisory experience required

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