Responsibility主要职责

·         Contribute to clinical study start-up, execution, close-out and
reporting at country and/or site level.

·         Assist local study team with preparation,
handling, distribution, filing and archiving of clinical documentation and
reports according to
company policies and SOPs.

·         Maintain Trial Master File (TMF) at country and/or site level per the
scope of work. Assist with periodic review of study files for completeness.
Preparation for relevant QC checks when applicable.

·         Track site compliance and performance per study timelines via Clinical
Systems (e.g. eTMF, CTMS, EDC, IRT system).

·         Manage,
coordinate, and track study materials, equipment and cost at country and/or
site level. Track site budget related matters, including processing invoices,
tracking payments, updating relevant trackers, coordinating the translation
of required documents.

·         Lead the
practical arrangements and contribute to the preparation of internal and
external meetings e.g. local study team meetings, monitor meetings,
Investigator meetings. Liaise with internal and external participants and/or
vendors at country and/or site level.

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

·         Provide
input into non-drug project work including training activities, meeting
events and development of work instructions as needed.

·         If needs
arise, may support CRAs for on-site visits to assist with clinical monitoring
duties upon completion of required trainings and with required approval. May
perform assigned administrative tasks at study level.

·         Ensure compliance with company policies and
procedures relating to people, finance, technology, security and SHE (Safety,
Health and Environment).

·         Ability to understand the impact of
technology on projects and to use and develop computer skills while making
appropriate use of systems/software

·         Identify and report quality
issues along with corrective and preventive actions to Local study
leader/equivalent esp when its related to any data privacy, serious breaches
and/impact to the reputation of company and safeguard patients’ rights and
wellbeing.

Requirement任职要求

·         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

·         Good verbal and written communication and presentation
skills

·         work accurately, being proactive, independent and working
in a team

·         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

·         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,

·         Computer proficiency

·         Good knowledge of spoken and written English