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.
The annual base pay for this position ranges from $101,948 to $152,922. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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 authorization and employment eligibility verification requirements.
