Senior Manager, Study Start Up (Alexion)
Alexion has over 3,000 talented colleagues dedicated to serving people living with rare diseases in more than 50 countries around the world. Our global headquarters are based in Boston, Massachusetts and our EMEA headquarters are in Zürich, Switzerland and Barcelona, Spain. We also have a Research Center of Excellence in New Haven, Connecticut, global supply chain and operations headquarters in Ireland, as well as local and regional operations in countries around the world, including Poland.
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca focused on rare diseases, created following the 2021 acquisition of Alexion Pharmaceuticals, Inc
Alexion is implementing the R&D team in Poland to support expansion of the footprint and enhance Poland presence in our development plans. In this context, we are looking for the Study Start-up (SSU) Senior 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 Senior Manager works in close collaboration with CRAs, PMCO, Supporting functions,, study sites and the Clinical Trial Team (CTT) to ensure that site activation deliverables are achieved in a timely and efficient manner. In addition, they will have responsibility for actively interacting with Health Authorities within their respective country/region and may be responsible for submission and approval processes across multiple countries.
The SSU Senior 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 Senior 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/HCO 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.
Extensive interactions with Health Authorities in assigned countries or regions to facilitate the submission and queries to ensure successful country approval.
May be responsible for multiple countries, ensuring successful submission strategy and execution where needed.
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 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:
Minimum 6 years of Study Startup experience
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Bachelors degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of relevant local regulations in each of the countries responsible (as applicable)
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.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
