.Location: Barcelona, SpainJob reference: R-211102Date posted: 10/17/2024Location: Barcelona, Spain (on-site) / 3 days working from the office and 2 days working from homeThis is what you will do:The Global Study Associate Director (GSAD) is a business-critical role whose mainaccountability isthe deliveryof clinical studies. The GSADis responsible to lead a cross-functional study team and provide the team with direction and guidance to enable successful study delivery. The GSAD isaccountabletothe GPTforthedeliveryofastudyaccordingtoagreedupon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.The GSAD leads the study team in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (r SOLID) and/or clinical outsourcing model (e.G., SCOPE), current clinical trial regulations (e.G. ICH GCP), current observational and post-marketing study regulations (e.G., GVP),Standard Operating Procedures (SOPs),policiesandbestpractices(e.G.Job aides,guidelines),andinlinewith Alexion's mission,values,andbehaviours.Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).You will be responsible for:- Leadandcoordinateacross-functionalstudyteamofexpertsinaccordancewith theinternal operating model (r SOLID) andoutsourced operating model (SCOPE)andits roles, accountabilities, and responsibilities framework (RACI) to ensure the clinical study progress as planned, driving achievement of milestones according to timelines, budget, and quality standards.- Develop and maintain relevant study documents/plans (e.G., global study management plan and its relevant components, etc.) including required input into clinical study protocol, clinical study report, and study level quality and risk management planning (e.G., risk-based quality management, proactive risk and contingency plans, inspection readiness plans, etc.).- [...] core and extended study team members as needed.- As the leader of the Clinical Trial Team (CTT), is the main point of contactfor the Global Project Team (GPT)/Global Medical Affairsand relevant Project Subteams, egthe Clinical Sub-Team (CST).- Accountable for study performance against agreed upon plans, milestones, and key performance indicators (KPIs, quality and operational).- Maintainstudy tracking systems and project timelines(e.G.,PLANIT,CTMS,TMFdashboard, etc.)andcommunicate any risks to timelines and/or quality to relevantprojects subteams, along with proposed mitigations.- Identify and report quality issues that have occurred within the study in accordance with relevant SOPs and collaborate with all functions as necessary to overcome barriers and [...] relevant stakeholders (e.G., CPT, quality assurance staff, functional line management, etc.)