Antal International Business Consulting (Beijing) Co., Ltd - Clinical Trial Leader (for I and II) , Beijing

About Company

Antal International is a leading international executive recruitment company - specializing primarily in the sourcing of middle to senior management employees for multinational companies.

For more information: www.antal.com


Job Description


Title: Clinical Trial Leader (for I and II)

Location: Beijing

Job Description: Responsible for the planning and implementation of all operational aspects of assigned Translational Medicine studies (e.g. medium to high complexity studies; first in man, patient studies, multi-center studies, mechanistic studies) from synopsis to reporting
according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).

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 and TM-SO Management; lead trial level interactions with internal line functions and external CROs e.g. those providing monitoring and site management services.
3. Function as a Lead CTL on studies for Full Development and assist in the coordination of TM related submission documents.
4. Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs
5. In collaboration with CRO management, CTT and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Initiation meeting
6. Support the CRA on study related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects eligibility
7. Responsible for set up and maintenance of the Trial Master File for assigned studies.
8. Regularly update all trial information databases in order to manage accuracy of information
9. Approve for all necessary center payments as per financial agreements.
10. In collaboration with the TME and CTT, 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.
11. Co-ordinate pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved.
12. Contribute to identification and evaluation of new centers suitable for performing TM studies in healthy volunteer and patients.
13. Responsible for implementation of best practices and standards for trial management within TM, including sharing lessons learned.
14. Provide TM-SO expertise to other departments and line functions e.g. Drug Supply Management (DSM), through e.g. cross-functional working groups or TM Initiatives.
15. Contribute to talent and career development of TM staff through active participation in on-boarding, training and mentoring activities.

Minimum requirements:

1. Bachelor degree in life sciences or nursing or clinical medicine for Peking University Health Science Center，Peking Union Medical College Hospital，Fudan University.

Or PhD level oversea learning experience in life sciences or nursing or clinical medicine

2. Fluent English (oral and written). Knowledge of a second language is desirable.
3. Gained relevant experience (preferred at least 2 years) in Translational medicine, Clinical Research or Research Nurse Experience (CRO, academic institution, hospital or industry), as judged from CV/interview
4.Potential to cope with both scientific aspects and operational tasks in a multidisciplinary organization (teamwork).
5. Knowledge of drug development process.
6. Capable of clear written and verbal expression of ideas, an active/proactive communicator.

Pls send your CV to SXu@antal.com.cn

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