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 ManagerLocation: 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 submission of 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.Coordinate with local COM team for preparation and submission of regular study progress reports.Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per start-up process and agreement with the clinical study team.Confirm debarment status of potential investigators.Act as a Sponsor local person for the regular update of local clinical trial registries according to local regulations, as applicable.May oversee SSU associates to ensure quality and compliance throughout the study startup process.You will need to have:Minimum 4 years of Study Startup experience.Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.Bachelor's degree in related discipline, preferably in life science, or equivalent qualification.Excellent knowledge of relevant local regulations.Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.Basic understanding of the drug development process.Excellent attention to details.Excellent written and verbal communication skills.Excellent collaboration and interpersonal skills.Excellent negotiation skills.The duties of this role are generally conducted in an office environment.
As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:Veeva Clinical Vault Experience.Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.Experience at CRO or Sponsor.Manages change with a positive approach for self, team, and the business.
Sees change as an opportunity to improve performance and add value to the business.
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