GlaxoSmithKline - Philadelphia, PA

posted 16 days ago

Full-time - Mid Level
Remote - Philadelphia, PA
Chemical Manufacturing

About the position

The US Clinical Trial Manager/US Local Delivery Lead is a remote role responsible for leading and managing the operational planning and delivery of Phase I-IV clinical trials in the United States. This position involves oversight of study activities, ensuring compliance with GSK standards and US regulations, and collaborating with various stakeholders to achieve study objectives. The role is pivotal in driving clinical operations and ensuring the successful delivery of clinical trials.

Responsibilities

  • Lead the US study team, providing matrix leadership and project management for study activities.
  • Serve as the operational point-of-contact between the central GSK study team and US study team.
  • Ensure critical study timelines are forecasted and achieved, meeting recruitment targets and data quality standards.
  • Accountable for the accuracy of study systems and reporting US study delivery progress to stakeholders.
  • Identify and resolve risks and issues impacting study delivery.
  • Provide feedback on performance and competencies of study members to line management.
  • Estimate, track, and deliver against the US budget for studies.
  • Advise on contract development with Sites/CRO/Vendors and participate in budget negotiations as needed.
  • Maintain knowledge of the study compound, protocol, and relevant US health care system requirements.

Requirements

  • Bachelor's degree (BA or BS).
  • 3+ years of experience as a clinical trial manager/local delivery lead managing clinical trial studies.
  • 3+ years of experience with budget and quality expectations in clinical development.
  • Experience managing and leading multiple studies, particularly in Infectious Diseases, Respiratory, Immunology, or Oncology.
  • Knowledge of GCP, internal company guidelines, and project management skills.

Nice-to-haves

  • Masters of Science, PhD, or equivalent with project management experience.
  • Experience in clinical development or the pharmaceutical field.
  • Excellent matrix leadership skills.
  • Solid operational knowledge of clinical research across all study lifecycle stages.
  • Strong problem-solving, negotiation, and conflict resolution skills.

Benefits

  • Health care and other insurance benefits for employee and family.
  • Retirement benefits.
  • Paid holidays and vacation.
  • Paid caregiver/parental and medical leave.
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