The Site Activation Team Specialist (SATS) has local responsibility for the delivery of site start up activities for assigned studies and are active participants in the MC study team(s). The SATS works in close collaboration with Monitors, Support Services, Research sites and the Local Study Delivery Team to ensure site activation is performed according to the Site Activation Plan. The site's deliverable must be of quality and timely. Risks to the plan must be flagged up to the LSL and SAT Lead.
The SATS is responsible for ensuring that all requirements for site activation are in place for the agreed number of centres in clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. Deliver according to the commitment in the individual trials and local saite activation process.
A SATS with longer tenure and experience may take on additional responsibilities that include additional tasks associated with Site Activation Team Leader (SATL). Major responsibilities
Additional Responsibilities May Include
- Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents.
- Assist in coordination and administration of clinical studies from start-up through site initiation/activation.
- Actively participate in local Study Delivery Team meetings and work cross functionally with Contracts, Feasibility and Study Support Services in US SM&M, this includes flagging risks to the site activation plan.
- Activate study sites in compliance with AZ Procedural Documents.
- Share information (metrics) on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required.
- Drive delivery of regulatory documents at the sites. Proactively identify delays in start up activities and the risks to the activation plan.
- Update IMPACT and other systems, including vendor spreadsheets, with data from centres as per required per SAT process.Proactively reach out to sites to ensure site supplies, binders, access to systems is achieved prior to SIV.
- Ensure regulatory binders and study supplies are provided for study site start up and/or delivered as per SAT process and agreement with Local Study Delivery Team. Ensure vendor supplies and access has been completed prior to SIV.
- Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and QA.
- Ensure compliance with AstraZeneca's Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensure completeness of the Study Master File for study start-up documents and site activation and ensure essential documents are filed in the TMF enterprise system (Veeva) and ANGEL, as appropriate.
- Ensure timely delivery of proper documents for support of study team submission to Regulatory Authorities.
- Ensure that all start up study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.
- Contribute to the production of study start up documents, ensuring template and version compliance.
- Create and/or import clinical-regulatory documents into the A New Global Electronic Library (ANGEL) according to the Global Document List (GDL) ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in ANGEL.
- Set-up, populate and accurately maintain information on a daily basis in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems.
Mi nimum Requirements and Preferred Background
- Contribute to process improvements, knowledge transfer and best practice sharing.
- Actively share applicable information that may be relevant to other functions.
- University degree in related discipline, preferably in life science, or equivalent qualification.
- Fluent knowledge of spoken and written English.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
Competencies and Skills
- Good knowledge of relevant local regulations.
- Good medical knowledge in relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Ability to deliver quality according to the requested standards.
- Ability to work in an environment of remote collaborators.
- 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.
- Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
- Good analytical and problem solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good cultural awareness.
- 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.
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A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca