- SGD Competitive Remuneration Package
- Research Engineering, Science
- Singapore - Singapore
The Clinical Research Manager will be ‘hands on’ and fully involved in technical/clinical aspects of the clinical trials to manage external company sponsored clinical trials. The management of the external company sponsored clinical trials involves Protocol design/development, Investigator Meetings, Investigator Brochure, Study Registration/Disclosure, Data analysis and Interpretation, Adverse event monitoring/analysis, Study report, Publication and Conference Presentation of the clinical trials. The responsibilities of the Clinical Research Manager include Review and Approval of all relevant Clinical documents required to conduct a clinical trial. The role would be tasked with identifying, developing and managing the Global Clinical capabilities, Global Clinical Research processes and Global Clinical Research personnel in collaboration with Clinical Operations in various therapeutic areas.
The ideal candidate has clinical and/or research experience in a multidisciplinary setting (Industry, Academia or Clinical/Contract Research Organisation). Knowledge of and experience within medical device industry is desirable. The post requires drive, a pro-active attitude, and attention to detail. The successful candidate can look forward to being part of an ambitious, cohesive, and multidisciplinary team working hard to achieve the development of novel products.
About the role
- Develop and manage Global Clinical capabilities and Clinical Investigators for various therapy areas including site assessments in collaboration with Clinical Operations.
- Develop and manage Global Clinical Research processes.
- Develop and manage Global Clinical Research personnel.
- Developing and writing trial protocols (outlining the purpose and methodology of a trial).
- Presenting trial protocols and reports to key stakeholders.
- Inputting into design of data collection forms, case report forms (CRFs).
- Coordinating with the contract research organisations (CROs)/hospitals/universities, ethics committee and internal clinical science team.
- Liaising with investigators on conduct of the trial.
- Setting up the trial sites, which includes training the site staff to trial-specific industry standards.
- Monitoring the trial throughout its duration from a Medical/Scientific/Clinical perspective, which involves visiting the trial sites on a regular basis.
- Verifying that data entered on to the CRFs is consistent with patient clinical notes.
- Writing visit reports and filing and collating trial documentation and reports.
- Discussing results with a biostatistician, responsible for writing technical trial reports.
- Select and manage vendors to assist in necessary operational aspects of running clinicals as budget and resources permit.
- Lead the ongoing review of clinical trial data (as needed), analysis and interpretation including the development of first interpretable results, clinical investigation and evaluation reports, publications and internal/external presentations. Including post-market follow up studies.
- Biomedical science Degree or other relevant degree or qualification.
- PhD would be an advantage.
- Minimum 7 years of experience conducting and managing clinical trials.
- Line management experience would be advantageous.
- Excellent knowledge of the clinical trials in Cosmetic, Medical Device, Pharmaceutical or CRO industry.
- Ability to work independently, creatively and with determination.
- Knowledge and understanding of the regulatory process and associated governance of medical devices. A working knowledge of Medical Device and IVD Directives.
- Excellent organisational and communication skills
- Work closely with a range of skill sets within the project team.
- Self-starting and motivated to make the clinical science research team efficient and effective.
Experienced in the use of the following:
- ICH GCP guidelines.
- ISO 14155: 2011* Clinical investigation of medical devices for human subjects - Good Clinical Practice.
- Proven experience of managing clinical investigations and evaluations from planning, obtaining ethics committee approvals, implementation and successful completion.
- Medical writing skills essential.
- Statistical analysis skills advantageous.
- Hands-on, collaborative, innovative, demonstrating leadership, ownership and accountability for medical affairs and/or clinical research whilst building strong relationships with all internal stakeholders.
- Able to manage complexity.
BenefitsDyson Singapore monitors the market to ensure competitive salaries and bonuses. Beyond that, you’ll enjoy a transport allowance and comprehensive medical care and insurance. But financial benefits are just the start of a Dyson career. Professional growth, leadership development and new opportunities abound, driven by regular reviews and dynamic workshops. And with a vibrant culture, the latest devices and a relaxed dress code reflecting our engineering spirit, it’s an exciting team environment geared to fuelling and realising ambition.
We are following the government guidelines regarding COVID19. At this time all interviews will be conducted via video or telephone. We’re taking these precautionary measures to protect both our employee and candidate wellbeing. Our Talent Acquisition team will work with you and provide further information as appropriate.