Study Administrator - Wilmington, DE | Biospace
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Study Administrator

AstraZeneca Pharmaceuticals LP

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Location:
Wilmington, DE
Posted Date:
9/23/2017
Position Type:
Full time
Job Code:
R-013838
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Wilmington,
Delaware,
United States
Job reference: R-013838

Posted date: Sep. 07, 2017

Study Administrator – Wilmington, DE

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As aStudy Administrator in
Wilmington, DE
you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

Main Duties and Responsibilities

The Study Administrator (SA) assists in the coordination and administration of the interventional study activities and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

  • Assist in coordination and administration of clinical studies from the start-up to execution and close-out.
  • Collect, assist in preparation, review and tracking of documents for the application process (RA/IEC). Interface with Investigators, external service provider and CRAs during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs and/or the LSTL until finalization of the study.
  • Operational responsibility to set-up the local Trial Master File (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF.
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance. Translate or give the appropriate support with the translation of documents when required.
  • 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
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities (not for international studies).
  • Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
  • Contractual support of study delivery, suggests appropriate payment by investigator and supports in negotiations with sites and investigators
  • HCP payments compliance to regulations
  • Manage and contribute to coordination and tracking of study materials and equipment
  • Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
  • Lead the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors
  • Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites
  • Responsible for layout and language control, copying and distribution of documents. Support with local translation and spell checks in English to/from local language
  • Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study related e-mails
  • Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents (International studies)
  • Additional country-specific tasks depending on country need

Requirements

Essential Requirements

  • Level of education that supports Skills and Capabilities of the position and ensures successful conduct of accountabilities/responsibilities and appropriate interactions with internal/external customers, completed high school and further studies in administration.
  • Previous administrative experience
  • Proven organizational and administrative skills
  • Computer proficiency
  • Very good knowledge of spoken and written English
  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
  • Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
  • Good interpersonal skills and ability to work in an international team environment
  • Willingness and ability to train others on study administration procedures
  • Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities

    Next Steps – Apply today!

    To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

    AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised