Project Manager

Are you an experienced Project Manager in life sciences, passionate about driving change in clinical trial execution? We are hiring a Regulatory, Quality & Safety (RQS) Project Manager to support a major transformation initiative focused on reimagining clinical trial operations across global R&D. In this role, you will work cross-functionally with senior stakeholders in Regulatory Affairs, Quality, and Clinical Operations to drive alignment, deliver workstream milestones, and shape scalable processes. This is a high-impact role ideal for individuals with strong program leadership experience, combined with expertise in regulated environments (GCP, regulatory, or clinical).

About the Role

-Lead and coordinate RQS contributions across 5 strategic workstreams:

1. Operating Model
2. Transactional Systems
3. Capability Building
4. Resource & Capacity Planning

-Define and execute a comprehensive project plan with clear deliverables, timelines, and risk mitigation strategies.

-Act as the central point of alignment across Regulatory, Quality, and Safety functions—bridging internal silos and ensuring consistency.

-Facilitate workstream meetings, track milestones, manage documentation, and drive cross-team communication.

-Identify, manage, and escalate project risks or misalignments to senior leadership and governance boards.

-Connect dots across technical, operational, and change management topics, ensuring that clinical systems and processes are interconnected and future-ready.

-Summarize status updates, drive cross-functional engagement, and coordinate backfill and resourcing needs.

Must Qualifications

1. Minimum 6–8 years of project or program management in the pharmaceutical or biotech industry
2. Experience in R&D environments: regulatory, clinical development, or quality
3. Strong track record in cross-functional coordination and managing stakeholder expectations
4. Familiarity with clinical trial processes, GCP principles, or regulated systems
5. Proven ability to work in global matrix organizations
6. Excellent communication, facilitation, and documentation skills
7. Fluency in English (written and spoken)

Nice-to-Haves

1. Hands-on experience in clinical trial operations, regulatory project delivery, or quality system implementation
2. Experience working with FSP/CRO models or clinical trial vendors
3. Familiarity with digital systems transformation or capability building programs

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Project Management and Other

Industries

Biotechnology Research and Pharmaceutical Manufacturing