Clinical Principal Investigator
10 hours ago
Position Summary - Purpose and Objectives of the Role
This position reports to the Clinical Investigations Team Manager, as part of the Research Institution “Essilor R&D Center Singapore”. The other members part of the Research Institution are Vision Scientists, Principal Investigators, Investigators, Biostatisticians and Data Analysts.
Since January 2021, the Essilor R&D Center Singapore is registered as a Research Institution to the Ministry Of Health in Singapore. First clinical investigations were launched since then, with more of them planned in the coming years. In particular, there is a need to conduct preliminary evaluations of medical device concepts on children, before confirming future developments and long-term clinical investigations.
Scope of Business/ Function - Key Areas of Expertise
As part of the Research Institution in Singapore, the Clinical Principal Investigator is responsible for:
the design, planning and setup of clinical investigations of medical devices concepts, whether they are conducted within the Research Institution or through an external collaboration,
the drafting of the protocol and all essential documents to be submitted to Independent Ethics Committees,
the supervision of investigators locally or abroad, in order to ensure that the clinical investigation is conducted in accordance with the protocol and applicable regulations,
the analysis, reporting and capitalization of the results.
Key Areas of Responsibilities
1. Design and planning of clinical investigation
Participate to the establishment of Clinical Evaluation plans with global R&D teams and Regulatory affairs representatives
Design clinical investigations and organize the setup in the relevant location
Drafts or supervises the drafting of all essential documents, in particular of the protocol
Establish thorough statistical analysis and data management plan
Submit all necessary documents to the Institutional Review Board (IRB)
2. Conduct of clinical investigation in strict compliance with applicable regulations
Train and supervise the investigators team
Ensure data integrity during the course of clinical investigations.
Comply with Good Clinical Practices (GCP), Human Biomedical Research Act (HBRA), and Personal Data Protection Act (PDPA).
Manage all adverse events and inform relevant authorities in due time.
3. Data analysis and result communication
Conduct statistical analysis and work closely with biostatisticians and data analysts from the team
Lead the discussion around the results within the organization (up to R&D management)
Write reports
Present clinical investigation results
4. Management of external collaborations
Coordinate agreements drafting with local and global legal teams
Monitor the sponsored clinical investigations
Nurture good relationship with our regional partners.
Key Requirements
Operated as Principal Investigator in R&D Healthcare private or public sector.
At least 5yrs of working experience in relevant fields.
Track record in healthcare research, and specifically in designing and managing clinical investigations on Medical Devices.
Min Master's degree in Optometry/ Clinical Practice/Public Health
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