.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.Study Start Up Manager Location : REMOTEThis is what you will do: The Study Start-up (SSU) Manager has local/country responsibility for the delivery of site start-up activities for assigned studies and is an active participant in the clinical study team(s). The SSU Manager works in close collaboration with Monitors, Support Services, study sites, and the clinical study team to ensure that site activation deliverables are achieved in a timely and efficient manner. The SSU Manager is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to Alexion/AstraZeneca Procedural Documents, international guidelines such as ICH and GCP, as well as relevant local regulations. The SSU Manager will deliver according to the commitment in the individual studies and local site activation process.You will be responsible for: Coordination and administration of start-up activities of clinical studies from site identification through site activation.Obtain and maintain essential documentation in compliance with ICH-GCP, Alexion/AstraZeneca Procedural Documents.Under supervision from the COM Team and other relevant stakeholders (i.E., Legal, ClinOps, etc.), assist in negotiations of budget and contract with site resolution of issues and contract execution.Assist in producing and collecting site-specific contracts, ICFs, and CDAs from country and/or master template.Coordinate with relevant stakeholders to generate responses to Ethics/IRB, RA queries during the evaluation period of the study; proceed with submissionof the responses within timelines.Prepare ongoing submissions, amendments, and periodic notifications required by central and local EC/IRBs, and other Regulatory Authorities as needed within the country; includes safety notifications as required by local regulations, with oversight from the COM team.Share information (metrics) on study site progress towards activation within local clinical study teams and Senior Management as required.Drive delivery of regulatory documents at the sites.Proactively identify delays in start-up activities and the risks to the activation plan.Review and collect essential regulatory documents for filing in eTMF.Set-up, populate, and accurately maintain information in Alexion's tracking and communication tools (e.G., Veeva Vault, SharePoint, etc.) and support others in the usage of these systems
