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Site Activation Team Specialist

Location Wilmington, Delaware, United States Job ID R-112104 Date posted 24/06/2021

The Site Activation Team Specialist (SATS) has local responsibility for the delivery of site start-up activities for assigned studies and is an active participant in the US study team(s). The SATS works in close collaboration with Monitors, Support Services, Research sites, and the Local Study Delivery Team to ensure that quality and quantity of site activation deliverables are achieved in a timely and efficient manner.

The SATS is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers 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 site 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).

Typical Accountabilities:

  • 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 activation.

  • Actively participate in local Study Delivery Team meetings and work cross-functionally with Contracts, Feasibility, and Study Support Services in US SM&M.

  • 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.

  • Primary reviewer of site-level Informed Consent Forms

  • Update Veeva Clinical Vault (VCV) and other systems with data from centers as required per SAT process.

  • Ensure regulatory binders and study supplies are provided for study site start-up and/or delivered as per SAT process and agreement with the Local Study Delivery Team.

  • 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).

  • 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 the 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 in AstraZeneca tracking and communication tools (e.g. Veeva, MS Teams, Box, etc) and support others in the usage of these systems.

Additional Responsibilities May Include

  • Contribute to process improvements, knowledge transfer, and best practice sharing.

  • Actively share applicable information that may be relevant to other functions.

Education, Qualifications, Skills, and Experience

Essential:

  • University degree in a related discipline, preferably in life science, or equivalent qualification.

  • 2+ years Start-up experience

  • 1+ years Veeva eTMF experience

  • Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP. Good knowledge of relevant

  • local regulations.
    •    Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.
    •    Ability to deliver quality according to the requested standards.
    •    Good analytical and problem-solving skills.
    •    Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
    •    Basic understanding of the drug development process.
    •    Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.

Desirable:

  • Oncology start-up experience

  • Veeva CTMS experience

  • Ability to work in an environment of remote collaborators.

  • Manages change with a positive approach for the 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 a reduced budget and in less time.

  • 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.

AstraZeneca Values

  • We follow the science

  • We put patients first

  • We play to win

  • We do the right thing

  • We are entrepreneurial

Key stakeholders and relationships

Internal:

  • Site Activation Team

  • LSMs and Local Study Teams

  • Line Manager

  • ADSMM and local SMM LT

  • Clinical Quality Manager

  • Local Medical Teams: MSLs and Medical Affairs

  • Global Study Team

  • Enablement functions

  • Clinical Data Management

  • Regulatory Affairs

External:

  • Investigators and site personnel

  • EC/IRB

  • Study-related vendors

  • Inspectors



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.

50056678 D CDSM R&D BioPharmaceuticals

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