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 integral 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-*-Ljbffr

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