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 46 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.
About the CompanyOur 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-fun...
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 46 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.
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