Clinical Operations Project Manager (80–100%)

About the Company
Our client is an innovative European biotech company advancing novel anti-infective therapies through clinical development. With several programs progressing from Phase 2 to Phase 3, the company is expanding its clinical operations team to strengthen execution, oversight, and cross-functional collaboration in upcoming global studies.

About the Role
The Clinical Operations Project Manager will manage the operational planning, coordination, and delivery of clinical trials within a small and agile biotech environment. Working closely with internal stakeholders, external partners, and CROs, this role requires hands-on involvement in study set-up, oversight, and execution.
It is a great opportunity for an experienced operations professional who enjoys both strategic planning and day-to-day execution in a fast-paced setting.

Main Responsibilities

• Manage and coordinate clinical trial activities from start-up to close-out, ensuring timelines, quality, and budget are met.
• Oversee CROs, vendors, and clinical sites, ensuring proper communication, performance, and issue resolution.
• Contribute to study planning, protocol and amendment reviews, and preparation of study-related documentation (e.g., plans, trackers, reports).
• ​​​​​​​Monitor study progress, metrics, and risk management; support data review and quality oversight.
• Ensure adherence to GCP, internal SOPs, and regulatory requirements across assigned studies.
• ​​​​​​​Collaborate closely with Medical, Regulatory, QA, and CMC functions to ensure smooth study execution.
• Support inspection readiness and audit preparation.
• ​​​​​​​Report operational progress and critical issues to senior management and project leadership.

Qualifications & Experience

• Degree in life sciences or a related field.
• Minimum 4–6 years of experience in clinical operations within biotech, pharma, or CRO environment.
• Proven track record in managing or coordinating global Phase 2/3 studies.
• Experience overseeing CROs and working within a lean biotech structure.
• ​​​​​​​Solid understanding of GCP, clinical trial processes, and regulatory frameworks.
• Hands-on, structured, and solution-oriented approach; able to work independently while collaborating across teams.
• ​​​​​​​Excellent communication and organizational skills.
• Fluency in English (written and spoken); additional languages are an asset.

Why This Role
This is a unique chance to join a growing biotech company at a pivotal time of clinical expansion. The position offers broad visibility across drug development and the opportunity to contribute meaningfully to the success of late-stage programs addressing major unmet medical needs.