Global Study Associate

2 tygodni temu

Warszawa, Mazovia, Polska AstraZeneca Pełny etat

At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

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 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

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.

Date Posted

23-maj-2024

Closing Date

31-maj-2024

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