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