China Job Listing

Title: Clinical Trial Leader Based in Shanghai/Beijing
Job Description

Responsibilities/Accountabilities:
1. Accountable for the writing of clinical protocols and related documents in collaboration with the Clinical trial Team (CTT): lead the clinical trial protocol development process; contribute to the operational and scientific input given for the development of trial-related documents and processes which reside in other line functions.
2. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT meetings (as needed), report study progress and issues to CTT; lead trial level interactions with internal line functions and external CROs
3. Function as a Lead CTL on studies for Full Development and assist in the coordination
4. of related submission documents.
5. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
6. In collaboration with CRO management, CTT and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting
7. Support the CRA on study related questions and serve as point of contact for managing/ answering questions relating to trial procedures and subjects eligibility
8. Responsible for set up and maintenance of the Trial Master File for assigned studies.
9. Regularly update all trial information databases in order to manage accuracy of information
10. Approve for all necessary center payments as per financial agreements.
11. Lead the ongoing review of the clinical trial medical/scientific data (as needed), analysis and interpretation including the development of first interpretable results, clinical trial reports, publications and internal/ external presentations.
12. Co-ordinate pre-audit activities for nominated projects ensuring a satisfactory outcome are achieved.

Requirement:
1. Gained relevant experience (preferred at least 2 years) in Translational medicine, Clinical Research or Research Nurse experience (CRO, academic institution, hospital or industry)
2. Potential to cope with both scientific aspects and operational tasks in a multidisciplinary organization.
3. Knowledge of drug development process.
4. Capable of clear written and verbal expression of ideas, an active/proactive communicator.
5. BSc or MSc in life sciences or nursing; PhD level scientist with life sciences background preferred
6. Languages: Fluent English (oral and written), knowledge of a second language is desirable.
* Please send us your complete resume (in Chinese and in English) to: 'topjob_hl024sh@dacare.com'(Please replace "#" with "@")
* In the email subject please include the position name and job #