Associate Director - Phase I Clinical Trial Manager

GlaxoSmithKline • Philadelphia, PA

406d • $136,000 - $184,000

About The Position

The Associate Director - Phase I Clinical Trial Manager at GSK is responsible for leading and managing the operational planning and delivery of Phase I clinical trials across various therapy areas. This role involves overseeing the US Phase 1 study portfolio, ensuring compliance with quality standards, regulations, and GSK's written standards. The position requires strategic collaboration with the US Leadership team and the ability to manage multiple priorities effectively while providing training and support to enhance team competencies in Phase 1 studies.

Requirements

• 7+ years of experience in Phase I study management
• Bachelor's degree in science or arts
• 10+ years' experience in clinical operations
• Strong project management skills
• Excellent matrix leadership skills
• Effective problem solving, negotiation, and conflict resolution skills
• Strong written and verbal communication skills in English
• Strong planning and organizational skills

Nice To Haves

• 2+ years' experience working in a Phase 1 unit
• Masters of Science, PhD or equivalent with previous project management experience
• Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field

Responsibilities

• Oversee the delivery of the US Phase 1 study portfolio and collaborate with the US Leadership team to plan the upcoming Phase 1 study pipeline.
• Create, deliver, and maintain Phase 1 training materials to support the US team.
• Conduct appropriate site qualifications for Phase 1 units that support studies.
• Ensure US delivery of assigned studies to time, budget, and quality expectations as defined in the clinical development plan and study protocol.
• Manage multiple priorities and responsibilities of increased scope and complexity.
• Forecast and achieve critical US study timelines and recruitment targets.
• Provide troubleshooting and problem resolution support for the within-country study team.
• Ensure the accuracy of study systems and reporting of study delivery progress to stakeholders.
• Identify and resolve or escalate issues and risks impacting study delivery.
• Provide feedback on performance and competencies of study members.

Benefits

• Health insurance
• Paid holidays
• Parental leave
• Retirement plan

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree