Clinical Principal Investigator

6 days ago

Singapore ESSILOR AMERA PTE. LTD. Full time

**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 Optmetry/ Clinical Practice/Public Health

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