Senior Early-Phase Clinical Project Lead

Syneos Health/ inVentiv Health Commercial LLC

Morrisville (NC)

On-site

USD 130,000 - 180,000

Full time

8 days ago
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Job summary

Syneos Health is seeking an experienced Sr Clinical Project Manager for Early Phase studies in the United States. You will oversee Phase I trials from startup through closeout, acting as the primary sponsor liaison and ensuring adherence to GCP, ICH, and regulatory standards.

The role requires strong leadership of cross-functional teams, robust budget and timeline management, and a deep understanding of early clinical development challenges, including FIH, SAD, MAD, and related exploratory

Qualifications

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or related field.
  • 5+ years clinical research with progressive project management responsibilities.
  • Experience managing Phase I/early-phase trials.
  • Strong knowledge of GCP, ICH guidelines, and global regulations.
  • Willingness to travel ~25%.

Responsibilities

  • Lead all aspects of assigned early-phase trials from startup to closeout.
  • Serve as primary liaison between sponsors, internal teams, vendors, and sites.
  • Develop and manage timelines, milestones, budgets, risks, and deliverables.
  • Ensure projects comply with protocols, SOPs, and regulatory requirements.
  • Lead cross-functional teams to meet quality, timelines, and budget.

Skills

Project management
Stakeholder management
Communication skills
Risk management
Independent work

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS
eTMF
Clinical trial systems

Job description

Syneos Health is seeking an experienced Sr Clinical Project Manager for Early Phase studies in the United States. You will oversee Phase I trials from startup through closeout, acting as the primary sponsor liaison and ensuring adherence to GCP, ICH, and regulatory standards.

The role requires strong leadership of cross-functional teams, robust budget and timeline management, and a deep understanding of early clinical development challenges, including FIH, SAD, MAD, and related exploratory

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