Global Study Associate V&I

Accountabilities/Responsibilities:

• Contribute to clinical study start-up, execution, close-out and reporting

• Collect, review and track regulatory and other relevant documents. Interface with Investigators, Strategic Partners, Site Management & Monitoring and internal staff during the collection process to support effective delivery of a study and its regulatory documents through finalization of the Clinical Study Report (CSR)

• Initiate and lead the set-up of the  electronic Trial Master File (eTMF) including tracking of documents. Maintain and close the  eTMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance

• Initiate and maintain production of study documents, ensuring template and version compliance

• Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) and maintain documents according to current process ensuring compliance with the AstraZeneca Authoring Guide for Regulatory Documents to support publishing in GEL

• 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

• Plan and proactively collate the administrative appendices for the CSR

• Interface with Data Management Centre and/or Data Management Enablement representatives to facilitate the delivery of study related documents

• Coordinate administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs

• Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites

Minimum Requirements

Education and Experience

• Relevant experience from within the pharmaceutical industry or similar organization, preferably of at least 1 years - knowledge of clinical development / drug development process in various phases of development and therapy areas;

• 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

• Proven organizational and analytical skills

• Previous administrative training/experience

• Computer proficiency

• Excellent knowledge of spoken and written English

• Project management experience - desirable

Skills and Capabilities

• Develop 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

• Excellent verbal and written communication and presentation skills

• Demonstrate ability to work independently, as well as in a team environment

• Ability to prioritise and manage multiple tasks with conflicting deadlines

• Good interpersonal skills and ability to work in a team environment

Date Posted

Closing Date

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.