Clinical Trial Scientist(Beijing)
We are recruiting a Clinical Trial Scientist and the key duties and responsibilities of this opportunity include -
- Implements and maintains the Scientific & Technical Review process involved for new protocols. Previews all protocols upon reception from Sales or Contract & Proposals and assists with the appropriate Lab Requirements based on the study design. Ensures the review is performed within the requested timeframe. Completes the appropriate paperwork as per relevant SOP.
- Recommends outside reference lab sources for testing, if necessary. In this case, contacts the potential reference labs using the appropriate request form documents and discuss the various technical opportunities relating to the testing required.
- For Biomarkers requested in the protocol under review, determines in collaboration with the ADL Director and the Lab Directors (or designee) if internal capabilities are available to cover for the requested analyses. Contributes to the evaluation of the production costs of any new Biomarker by the use of appropriate tools approved by Finance.
- Contributes to researching the most appropriate set of Biomarkers that may be suggested to the Sponsor in view of the study goal and design, in the context of putting together an added value proposal at the time of budget submission or shortly afterwards. This step may involve web-based literature search as well as making contacts with appropriate academic centers, as required.
- Checks for harmonization of instruments, methods, and reference ranges throughout the global laboratories, for each new protocol under review. Participates in the Global Technical Harmonization Committee as required.
- In collaboration with the Global Harmonization group, contributes to updating the Compendium of Tests for all analytes tested at each lab location, as missing or inaccurate information is being found. Also, researches and co-ordinates changes and additions to the Global Range Definition and Unit Conversion Factor tables and maintains records to support the required changes, as per required study protocols.
- In collaboration with the CSO, the Director of Scientific and Technical review and the Lab Directors, contributes to completing RFPs and reviewing early stage protocols submitted through CDS partnerships.
- Assists Project Management, Business Development and other QLAB departments with Quality Assurance checkpoints, process control and project planning.
- In collaboration with the ADL, assists with the design, performance and evaluation of analyte stability studies as required.
- Actively participates in the drafting of SOPs for new processes put into service on a global basis. Also, actively communicates with technical counterparts located at other facilities to ensure harmonization of the Scientific and technical review processes.
- Provides training and guidance to Contract and proposal staff, in view of permitting the upstream triaging of the protocols which do not require a dedicated scientific and technical review.
- Participates in Client meetings (bid defense, capability presentation…) or teleconferences as per identified needs.
- Bachelor’s degree or MT to PhD degree in the medical field and extensive experience in the clinical laboratory environment including experience with all areas of the clinical laboratory and new assay development, or other comparable combination of education, training and experience.
- Posses a general knowledge of clinical laboratory regulations, ICH and GxP guidelines.
- Possess effective communication skills, both written and verbal.
- Must be detail oriented with excellent organizational skills.
- Must be open to travelling
- Position requires extensive use of the telephone and face-to-face communications, which requires the accurate perception of speech. Must be able to work efficiently in a fast paced environment. Position also requires keyboarding involving repetitive motions with fingers and sitting for long periods of time.
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