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 general 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 global requirements
* Strong project management skillsets
* Excellent communication skills and ability to manage cross functional teams
* Ability to deal with complex situations and drive solution orientated thinking
* Fluent in English
* Excellent team player, ability to work under high pressure and pronounced resiliency
* Experience working in an international and cross-functional team
* Ability to present and defend the perspective
* Experienced in Microsoft project, Excel, Power point Other Tasks:
* Participate in relevant meetings
* Plan and set up cross-functional meetings, meetings with vendors and others as needed
* Own and/or contribute to SOP development /reviews
* Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required #J-18808-Ljbffr

📌 Senior Manager Clinical Operations (Cataluña)
🏢 Fresenius
📍 Cataluña