Location: Spain and HungaryFunctional 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 pointOther 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 (M/F/D) (Barcelona)
🏢 Fresenius Se Kgaa
📍 Barcelona