- SGD Competitive Remuneration Package
- Research Engineering, Science
- Singapore - Singapore
The Clinical Operations and Project Manager may be required to conduct internal consumer testing trials and will responsible for all aspects of the human subject trials with medical devices and cosmetics within the company from trial plan, risk assessment, safety approval, volunteer recruitment, maintaining provision of trial supplies including the trial devices, trial conduct, analysis and reporting.
The ideal candidate has clinical and/or research experience in a multidisciplinary setting (company or CRO). 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
- Assume responsibility for management of clinical operations at trial and site level.
- Develop clinical strategy for products in coordination with regulatory and marketing strategies.
- Manage vendor and CRO activities and track internal and external project deliverables.
- Participate in clinical research activities and assist in management of clinical study sites, management of study documentation, and completion of project management tasks.
- Prepare and maintain Clinical Study Files - Trial Master Files, Investigator Site File, Investigator File, study essential documents and regulatory documents.
- Work with CRO to prepare Ethics committee document for submission and other tools, templates and documents before clinical site initiation.
- Develop clinical trial timelines, enrolment projections, documents and instructional materials, including project management, monitoring, recruitment, and risk management.
- Support Post-Market Clinical Follow-up and clinical vigilance reporting and internal investigation.
- Support annual updating of Clinical Evaluation Report evaluation report for commercialised devices devices.
- Maintain effective working relationships with investigators/investigational site research coordinators, and vendors including core labs, data management, and CROs.
- Upload cases and enter biometrics for assigned clinical studies.
- Liaise closely with a multidisciplinary team to coordinate pilot production of new products.
- Co-ordinate internal company consumer testing, including trial design, interfacing with internal safety review boards (application and approval); and data (safety and privacy) management.
- Contribute to the consumer testing design and assessment technologies.
- Provide general administrative support to Clinical Affairs function and assistance to Project Managers and Project Team.
- Assist in completion of all required tasks to meet departmental and project goals.
- Assist with compiling trial data that will contribute to reports based on this research.
- Assist in the development and implementation of recruitment strategies to increase trial participant recruitment.
- Manage trial site files and manage trial participant queries for the research studies.
- Co-ordinate trial participant visits according to the trial protocol.
- Co-ordinate pre-trial medical questionnaire for participants.
- Assist project teams with study specific documentation including Risk assessments, Trial protocols, Questionnaires, Reports, Review documents etc.
- Set up, organize and maintain trial documentation including preparation for internal reviews and archival.
- Process data collection forms i.e. Questionnaires
- Co-ordinate ordering/dispatch and tracking of trial materials as appropriate.
- Assist project teams with trial progress tracking by updating the Project time-plans.
- Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
- Assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.
- To be familiar with ICH GCP, appropriate regulations, relevant ICON SOP’s and ICON internal tracking systems. All duties must be performed to Good Clinical Practice standards as laid out by the International Conference on Harmonisation.
- Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable training will be made available to enable individuals to perform the essential functions.
- Degree in Biology, Life Sciences, Biotechnology or equivalent
- At least 3 years of clinical affairs experience
- Experience in registry studies and investigator-initiated studies will be preferred
- Familiarity with medical device regulations MDR, quality management system (ISO 13485), (21 CFR Part 820), and other medical ISO standards
- Occasional travel to conduct site visits/vendor audits etc.
- Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
- Good written and verbal communication skills.
- Good written and spoken English.
- Computer literacy e.g. Microsoft Word, Excel, PowerPoint, Outlook
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.