Hybrid Senior Clinical PM – Early-Phase Trials, Boston

Stealth Mode Biotech

Massachusetts

Híbrido

USD 140.000 - 190.000

Jornada completa

Hace 13 días

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Descripción de la vacante

Stealth Mode Biotech in the Boston area seeks a proactive Clinical Project Manager to plan, coordinate, and execute early-phase clinical trials from startup to closeout. You will partner with internal teams, CROs, sites, and vendors to keep timelines, milestones, and budgets aligned with GCP and regulatory requirements.

The role requires 10+ years in clinical operations, proven experience with study startup, enrollment acceleration, and vendor oversight in a lean biotech setting.

Formación

  • 10+ years in clinical operations, clinical study management, or clinical project management within biotech/pharma
  • Experience with early-phase trials (Phase I/II) and aggressive enrollment targets
  • Experience overseeing CROs and external vendors with deliverable accountability

Responsabilidades

  • Clinical Trial Planning and Execution from startup through closeout
  • Site activation, enrollment planning, and feasibility assessments
  • CRO/vendor selection, oversight, and issue resolution
  • Timeline, milestone, and budget management across functions
  • Cross-functional coordination with Regulatory, Data Management, Biostatistics, Safety, Medical, Quality
  • External partner coordination with imaging and central laboratory vendors
  • Risk and issue management with mitigation planning
  • Regular status reporting and stakeholder communication
  • Study closeout activities and archival documentation

Conocimientos

Program management
Cross-functional leadership
Vendor management
GCP compliance

Educación

Bachelors degree in life sciences or related field
Advanced degree preferred

Descripción del empleo

Stealth Mode Biotech in the Boston area seeks a proactive Clinical Project Manager to plan, coordinate, and execute early-phase clinical trials from startup to closeout. You will partner with internal teams, CROs, sites, and vendors to keep timelines, milestones, and budgets aligned with GCP and regulatory requirements.

The role requires 10+ years in clinical operations, proven experience with study startup, enrollment acceleration, and vendor oversight in a lean biotech setting.

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