上海招聘

职位描述：
Description:
Participate in the coordination of and contribute to operational (activities to ensure quality and consistency of Operations deliverables to time, cost, and quality objectives from Study Specifications (SS) through study close-out activities and Clinical Study Report (CSR).

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
?Provide input into non-drug project work including training activities and development of procedures as needed
?Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, ISSIS, Clinical Partners Portal and SharePoint) and support others in the usage of these systems
?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, ISS review meetings, monitor meetings, Investigator meetings. Liase with internal and external participants and/or vendors
?Prepare, contribute to and distribute presentation material for meetings, newsletters and web-sites


Minimum Requirements –Education and Experience
?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

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
?Willingness to travel both domestically and internationally
?Proactively identify risks and possible solutions
?Demonstrate analytical thinking, concern for standards, concern for impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control, tenacity conflict resolution skills and the ability to influence others
?Develop knowledge of therapy area through experience and review of scientific literature
?Ability to prepare presentation materials
?Demonstrate professionalism and mutual respect
?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

Leadership Capabilities at level 1
?Commitment to Customers and Integrity
?Strategic Leadership
?Acts Decisively
?Drives Accountability
?Works Collaboratively

Internal and External Contacts/Customers - Some examples of contacts/customers are:
?Operations personnel
?Data Management Centre representatives
?Clinical Project Team and therapy area personnel
?Clinical Development personnel
?External service providers and strategic partners
?Study Site personnel
?Site Management & Monitoring personnel
?Other Skill Centres as appropriate 举报 分享

阿斯利康是一家以研发为核心的生物制药企业。
通过优质的药物为医药带来意义深远的改变是我们的使命。为了服务患者未被满足的医疗需求，我们坚持对卓越科研实力的不断追求。
我们的专长涵盖药物的整个生命周期，在小分子和生物制剂领域都有所实力。通过运用这些领域的实力，我们寻找包括单一疗法和组合疗法在内的不同方式应对未被满足的医疗需求。

AstraZeneca is a global biopharmaceutical company with research and development at its core.
Our mission is to make a meaningful difference to healthcare through great medicines. This is founded on the pursuit of scientific excellence that addresses unmet patient need.
Our expertise spans the entire life-cycle of a medicine and we have capabilities in both small molecules and biologics. This allows us to search for solutions to unmet medical needs using both modalities, individually or in combination.