.Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.Senior Manager, Clinical Project LeadLocation: Barcelona, SpainPosition SummaryThe Senior Manager, Clinical Project Lead is accountable for the study team and study deliverables and is the primary point of contact interfacing between functional groups, investigator sites, and vendors. The Senior Manager will drive the scope of work, partnering with our Country Operations Management teams, overseeing CROs as needed and proactively managing patient safety and data integrity to ensure inspection readiness and compliance. The Senior Manager, CPL will provide status updates and performance metrics and develop, review, and approve related study documents.Job Duties & ResponsibilitiesUnder direct supervision of the Director CPL, the Senior Manager CPL is accountable for the planning, implementation, and execution of clinical trials, including study deliverables, milestones, and data quality. Leads the Clinical Trial Team. Provides management oversight of CROs as needed and relevant study vendors. Reports to the Director CPL on trial metrics, issues, and rescue activities.Partners with our Country Operations Management teams to deliver studies in an insourced model and manages CRO relationships as needed to ensure the appropriate scope of work, oversight, and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget, and quality.Manages clinical study budgets within agreed variance.Communicates clinical studies performance data to other members of the management and scientific team.Prepares and maintains required study and regulatory documentation, e.G., reports for Competent Authority submissions, template informed consent, Monitoring Plan, Pharmacy Manual, investigator contracts, and budgets.Key contributor to the development, review, and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report.Conducts lessons learned exercise to help document continuous improvement process and sharing of best practices.Participates in and/or leads departmental initiatives.Essential Qualifications5 years of clinical research experience, 3 of which in a leading role accountable for the planning and execution of global clinical trials.Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development.Preferred QualificationsPMP certification desirable