My client is a leading player in the medical device industry and now seeks an experienced Clinical Research Associate
- Leading Name
- Excellent Products
- High Salary
- 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
- 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.
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).