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