Study Start-Up Manager

August 20, 2024

AstraZeneca

台北市

OTHER

Typically works independently with only moderate supervision and guidance in own knowledge area. Researches and analyses internal and external information to determine methodology choices. Is able to resolve complex issues within specialised area and participates in research projects.
Typically Accountabilities

Collects reviews and tracks regulatory and other relevant documents
Initiates and maintains production of documents, ensuring template and version compliance
Creates and/or imports clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the Astra Zeneca Authoring Guide for Regulatory Documents to support publishing in GEL
Contributes 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
Leads administrative appendices for the CSR
Provides input into non-drug project work including training activities and development of procedures as needed
Monitors the set-up and maintenance of information in Astra Zeneca tracking and communication tools (e.g. IMPACT, Clinical Partners Portal and e Room) and support others in the usage of these systems
Manages and coordinates tracking of study materials and equipment
Monitors administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs
Leads 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
Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites
Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration

Qualification

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
Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
Proven organizational and analytical skills
Ability to prioritise and manage multiple tasks with conflicting deadlines
Excellent knowledge of spoken and written English
Good interpersonal skills and ability to work in a team environment
Excellent verbal and written communication and presentation skills
Excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
Ability to prepare presentation materials