Malaysia Clinical Quality Specialist

Highly Competitive
  1. Permanent
  2. Clinical Scientist
  3. Malaysia
Malaysia
Posting date: 12 Nov 2020
34123

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.

Job Responsibilities

  • 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.

To Apply:

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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