Description

Key Responsibilities

  • Own the project lifecycle from scope and schedule to risk and issue management.
  • Define project objectives and key milestones; clearly communicate roles, deliverables, and timelines to team members.
  • Lead cross-functional teams, collaborating closely with internal and external stakeholders to ensure alignment, efficiency, and results.
  • Provide regular, actionable updates to stakeholders and leadership, maintaining transparency and momentum.
  • Create and manage project documentation, SOPs, and presentations. Facilitate meetings, draft agendas and minutes, and follow through on action items.
  • Identify risks proactively and implement effective mitigation strategies. Escalate issues appropriately to maintain project integrity.
  • Track project health and metrics, using data to guide decision-making and keep projects on target.
  • Foster a culture of accountability, continuous improvement, and excellence.

Education and Experience

  • Bachelor's degree in a life sciences or related field.
  • At least 3 years of project management experience in a regulated industry; clinical trial experience strongly preferred.
  • Solid grounding in Agile methodologies and a scientific/technical foundation.
  • Deep understanding of FDA regulations (including GCP and 21 CFR).
  • PMP certification is a plus.

Knowledge, Skills and Abilities

  • A strategic thinker with proven success managing multiple complex projects on time and within scope.
  • A communicator who inspires trust—clear, concise, and collaborative.
  • Calm under pressure, flexible, and solution-oriented in a dynamic environment.
  • Detail-obsessed and quality-focused, with a commitment to integrity and process excellence.
  • Skilled at building consensus, resolving conflicts, and leading without direct authority.
  • Self-driven, organized, and able to prioritize competing demands

Education

Bachelor's degree