Clinical Study Administrator

Clinical Study Administrator (CSA)within Country Operations Management (COM)Responsible for coordinating study activities from start-up to execution and close-out, ensuring quality and consistency in trial deliverables and meeting time, cost, and quality objectives in accordance with Good Clinical Practice (GCP), Alexion Standard Operating Procedures (SOPs), and evolving regulatory requirements.ResponsibilitiesProvide support to the local study team in COM to achieve quality and timeliness of study deliverables across the lifecycle of assigned trials.Manage end-to-end electronic Trial Master File (eTMF) set-up and maintenance, regulatory document tracking, team training, documentation milestone management in the Clinical Trial Management System (CTMS), and other general trial support.Support start-up activities including CDA delivery and negotiation, document distribution and collection, communication with sites during contract negotiation, Site File preparation, and site activation approval.Collaborate with PMCO CRAs, SSU managers, and study vendors on clinical trial supplies preparation, handling, distribution, and tracking information maintenance.Act as a central point of contact for designated project communications, correspondence, and associated documentation.Input on the development and maintenance of project management and other global tracking tools.Collaborate in global initiatives to standardize processes within and across countries.Assist with local language translations, IRB/CEC/CA submissions in collaboration with Regulatory Affairs and other functions.Provide support for local COM team meetings, teleconferences, and staff onboarding as required.Depending on the country/region, provide varying levels of COM support to the department rather than assigned studies as needed.Essential Skills / ExperienceBachelor's degree in a related discipline preferably life science.Proficiency with MS Office Suite (Excel, Word, PowerPoint).Understanding of the drug development process either through education or experience in the life sciences field.Preferably minimum experience of 2 years in development.Excellent collaboration and interpersonal skills; unafraid to ask questions.Strong organizational skills and ability to manage competing priorities.Strong attention to detail.Effective written and verbal communication skills.Desirable Skills / ExperiencePrior experience working in clinical research.Medical knowledge and ability to learn relevant Alexion rare disease areas.Ability to work in an environment of remote collaborators and in a matrix reporting structure.Manages change with a positive approach for self, team, and the business; sees change as an opportunity to improve performance and add value.Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.Key SkillsAbinitioLifting EquipmentCustomer ServiceApache CommonsBusiness ManagementEmployment type: Full-TimeWork EnvironmentWe balance the expectation of being in the office while respecting individual flexibility.On average we work a minimum of 50 % of our days each month from the office, but flexibility is valued.Join us in a unique and ambitious world where innovation thrives.EEO StatementAlexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.The Company will not make decisions about employment, training, compensation, promotion and other terms and conditions of employment based on race, color, religion, creed, or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship, status, marital status, pregnancy (including childbirth, breastfeeding or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.Alexion provides reasonable accommodations to meet the needs of candidates and employees.To begin an interactive dialogue with Alexion regarding an accommodation please contact ...Alexion participates in E-Verify.Application DatesDate posted: 21-nov-****Closing date: 05-dic-****Number of vacancies: 1#J-*****-Ljbffr