Location: Spain and Hungary
Functional Goal:
Responsible for the strategic and tactical operational planning and execution of R&D; sponsored clinical programs for all corporate sponsored programs for Phase I - Phase IV.
Main Tasks:
- Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas.
- Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
- Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
- Lead (multiple) cross-functional teams and drive oversight of CRO's and vendor management and has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers, and key business drivers to increase effectiveness.




- Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.)
- Responsible for inspection readiness.
- Accountable for CAPAS related to clinical programs within the field of Clinical Operations.
- Accountable and responsible for the financial planning, budget, accruals, forecasts contribution.
- Preparing clinical program updates and/or contribution to them as needed.

Qualification profile:
- Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background
- At least 7 years' experience in clinical research in industry, and at least 5 years in clinical trial management
- Understanding GxP and integral requirements
- Strong project management skillsets
- Excellent communication skills and ability to manage cross functional teams
- Ability to

📌 Senior Manager Clinical Operations (Barcelona)
🏢 Fresenius Se Kgaa
📍 Barcelona