J****S
发帖数: 15 | 1 Pls contact: d******[email protected] for more information
Requirements:
1、BS in Clinical Medicine/Basic Medicine from top universities
2、Overseas Ph.D in lifescience(no clincal experiences need) / or have
clinical trial management experiences(no further degree needed)
Responsibilities:
1、Work as a CTL on Medium to High complexity studies including multi-
country / multi-centre trials and lead the Clinical Trial Team (CTT) in
development of the protocol and related documents.
*CTL will involve the following tasks / requirements.
*Author of the clinical study protocol and other study essential documents
*Responsible for ordering and management of clinical trial materials,
including drug supplies and CRFs
*In collaboration with CRO management, CTT and CRAs, identify sites and
manage study set-up, including responsibility for organizing and chairing
the Initiation meeting
* Support the CRA on study related questions and serve as point of contact
for managing/answering questions relating to trial procedures and subjects
eligibility
* Ensure the set up and maintenance the Trial Master File for assigned
studies.
* Ensure study progress and completion is according to specified timelines,
budget and quality standards.
* Responsible for chairing CTT meetings (as needed) and communication of
study progress to CTT and CS&I Management
* Regularly update all trial information databases in order to manage
accuracy of information
* Approve for all necessary center payments as per financial agreements.
2、Interaction with Investigator sites to ensure the smooth set up and
management of the study – whether as a support on a global level or for
individual study assigned.
3、Assist in data review and interactions with the Data Manager to bring in
third party datasets.
4、Responsible for report writing for own studies either directly
contributing to and managing the report writing or liaising with the medical
writing/narrative group to ensure report publication is completed according
to current requirement.
5、Ensure complete review of all study documentation at the end of the study
and transfer to archives
6、Responsible for the coordination of pre-audit activities for nominated
projects ensuring a satisfactory outcome is achieved.
7、Act as a mentor / Global CTL for a support / Local CTL and ensure
delegation of duties
8、Be assigned as lead CTL on a Project and attend the TS GPT Sub-Team
meetings / DA meetings as required.
9、May function as a CTA / CTL Coordinator and be delegated people
management tasks from the Head of Clinical Sciences.
10、Provide CS&I expertise to other departments and line functions e.g. CQA,
Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM)
and to cross-functional working groups as required. Function as a Subject
Matter Expert (as assigned)
11、Maintenance of knowledge and training of ICH-GCP, current regulations
and procedures. |
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