Oncogen Pharma (Malaysia) Sdn Bhd is looking for new potential candidates to fill in for Senior Executive, Clinical Affairs position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- To prepare, organize, manage as well as monitoring bioequivalence (BE) study/ clinical trials in-accordance with the ICH E6 GCP and any other applicable local SOP/GCP's.
- To plan, initiate and executing BE study/ clinical trial within allocated resources, budget and timeline.
- To develop, compile and review all study-related regulatory and administrative documents from investigational sites, study protocol, monitoring visit reports and other study related documents.
- To liase with Contract Research Organization (CRO) on all projects from start-up until receipt of final report.
- To perform monitoring aspects of BE study/ clinical trial as stated in ICH E6 GCP, local GCP's as and when required (lest than five (5) times per year)
- To manage and handling of investigational products.
- Possessed minimum of Bachelor Degree in Pharmacy/ Pharmacology or Bio Medical or equivalent.
- Certified in 'Good Clinical Practise (GCP)' course.
- Preferably candidate with a minimum of two (2) years of working experience in clinical research (pharmaceutical/ CRO industry) or monitor in BE/Clinical studies.
- Effective written and verbal communication skills as well as good command in English.
- Excellent in Microsoft Office applications (e.g. Word, Excel, Powerpoint)
- Good understanding in cross-functional processes, BE study/clinical trial processes.
How To Apply
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