The junior Clinical Operations Manager works under the hierarchical supervision of Head of the Clinical Operations Department.
Objective
The objective of the Junior Clinical Operations Manager at EORTC is to support the planning, coordination, and execution of clinical studies in compliance with regulatory and organizational standards. This role aims to ensure operational excellence by assisting in study set-up, monitoring timelines, and maintaining quality across all study activities.. Additionally, the Junior Clinical Operations Manager contributes to continuous process improvement and adherence to best practices in clinical research. Ultimately, the role supports the successful execution of clinical research projects aligned with EORTC’s mission to advance cancer treatment.
Main responsibilities / Major Activities
Non-project related responsibilities
- Contribute to improvement/development of clinical operations processes and tools according to individual competences and interest.
Project related responsibilities as of study set-up
- Manages the operational aspects during start and conduct of the project, at any time, such as but not limited to:
- Ensures adequate logistical and operational support to the study sites during the conduct of the study at any time.
- Supports site monitoring and control.
- Develops of study-specific guidelines and training for sites (e.g. pharmacy manual, lab manual).
- Manages drug supply (e.g. follow-up on necessary supplies to sites).
- Manages human biological material (e.g. follow-up on sample kit supplies to sites and sample shipment from sites to central laboratories).
- Follows up with collaborating intergroups regarding operational activities delegated to them.
- Communicates adequately with the various stakeholders and third parties on operational and logistical activities.
- Follows up on change management and escalates to Clinical Operations Manager, Project Manager and/or line manager, as appropriate.
- Maintains Trial Master File, Clinical Trial Management System and other tracking tools applicable to the study.
- Supports redaction of the study newsletters.
- Supports preparation of internal/external audits.
Profile
- Master’s degree in life sciences (biomedical sciences, pharmaceutical sciences…) with two years of experience in similar function.
- Team player who can work independently.
- Excellent communication skills.
- Able to prioritize adequately.
- Excellent knowledge of MS office tools.
- GCP certification is mandatory.
- Strong interest in EORTC mission.
- Excellent written and spoken English.
Benefits
