Das ist der Job
Location: Spain.
Darum lohnt es sich
Lead cross-functional teams and oversee CROs and vendor management, ensuring cross-functional teams jointly achieve trial objectives and goals. Excellent communication skills and ability to manage cross-functional teams. Excellent team player, able to work under high pressure and demonstrate pronounced resilience.
Experience working in an international and cross-functional team. Job Summary and Location Responsible for the strategic and tactical operational planning and execution of R&D sponsored clinical programs for all corporate-sponsored programs from Phase I to Phase IV.
Responsibilities Plan, coordinate, oversee, and conduct complex global clinical trials in one or more therapeutic areas. Collaborate in a global environment, applying best practices and knowledge of internal and external business issues to improve processes, standards, and services.
Accountable for planning, driving, and monitoring protocol-related activities throughout the project lifecycle to meet timelines, budget, and quality expectations. Understand agency requirements related to clinical packages and plans, managing functions such as CSR, TFLs, ISS, etc.
Ensure inspection readiness and manage CAPAs related to clinical programs within Clinical Operations. Accountable for financial planning, budget, accruals, and forecast contributions. Prepare clinical program updates and contribute to them as needed.
Qualifications Advance degree in life sciences (graduate degree), e.g., Biology, Chemistry, Pharmaceuticals, or a medical background. At least 7 years of experience in clinical research within industry, with at least 5 years in clinical trial management. Understanding of GxP and global requirements. Strong project management skillsets.
Ability to handle complex situations and drive solution-oriented thinking. Fluent in English. Ability to present and defend perspectives. Proficiency in Microsoft Project, Excel, and PowerPoint. Other Tasks Participate in relevant meetings. Plan and set up cross-functional meetings, vendor meetings, and other necessary discussions.
Own and/or contribute to SOP development and reviews. Support sponsor oversight through participation in site visits, including Site Initiation Visits (SIVs) and Co-Monitoring Visits, as required. #J-18808-Ljbffr
