Job Opportunities API

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 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