Malaysia Clinical Quality Specialist
Proclinical have partnered with leading CRO who are looking for a talented Clinical Quality Specialist to work with a leading Pharma company in Malaysia. This company has grown tremendously over the past few years and are now looking to expand their team.
- The successful candidate must have full knowledge of regulations relating to clinical research
- Is aware of the specificities for the clinical studies which he/she is responsible.
- Remaining compliant with the specific provisions of the protocol and agreements
- Ability to coordinates with team of CRAs, project Managers, the investigators and the clinical study sponsor.
- Under the responsibility of the Project Manager or Director of Clinical Operations, he/she ensures that clinical trials are properly followed through, that the scientific data collected during the clinical study is reliable.
- The Clinical Specialist will supervise and organise the work of Junior and intermediate CRA assigned, coordinate the project with other departments involved (Regulatory Affairs, Biometry).
- Assists the Project Manager to prepare and follow up submissions to the Ethics Committee and the relevant
- Makes sure that applicable Standard Operating Procedures (SOPs) are implemented and that all relevant information about clinical trials are reported to the correct department.
- Prepares the appropriate monitoring tools according to applicable SOPs, based on the protocol and the CRF.
- Assists the Project Manager with handling of SAE - SADEs.
Skills and Requirements
- Must have a degree in Life Science or related field
- Have Monitoring experience as CRA for over 5 years
- Has experience as a clinical lead or any other supervisory/leading role in clinical studies
- Experienced in coordination and preparation for site/CRO audit
- Keen in Training internal members on Quality
- Must be fluent in English and someone outspoken.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.