Study Start Up Manager

This 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 a member of local study team(s). The SSU Manager works in close collaboration with CRAs, PMCOs, Supporting functions, study sites and the Clinical Trial Team (CTT) 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 PMCO and other relevant stakeholders (i.e. Legal, ClinOps, etc.), assist in negotiations of budget and contract with site resolution of issues and contract execution.  

• Assists in producing and collecting site-specific contracts, ICFs and CDAs from country and/or master template.   

• Coordinates with relevant stakeholders to generate responses to Ethics/IRB, RA queries during the evaluation period of the study; proceeds with submission of the responses within timelines 

• Prepares 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, working with local study team in the country level.  

• Share information (metrics) on study site progress towards activation within local 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. 

• Coordinates with other local study team members 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 

• Confirms debarment status of potential investigators  

• Acts 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: 

• Bachelor's degree in related discipline, preferably in life science.  

• 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. 

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.  

• Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. 

• 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. 

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.