Careers
At AGTC We Are Data Geeks | Team Oriented Transparent | Quality Focused | Leaders
Associate Director, Clinical Project Management
- Job Title
- Associate Director, Clinical Project Management
- Job ID
- 27701279
- Work Hybrid
- Yes
- Location
- Hybrid, Based in UK,
- Other Location
- Description
-
Mission
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
- 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
- Bachelor’s degree
- Bachelor’s degree in a scientific discipline preferred
- 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 demands: (check one)
- Physical activity: (check all that apply)
- Visual acuity: reading, writing preparing/analyzing data
- Working conditions: indoor office environment
Previous management or supervisory experience required
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