My client is one of the global biotechnology companies with good reputation. Their clinical trials are moving to the phaseII/ III stage. Now, they're looking for talents who is keen to join pharmaceutical/ biotechnology companies for developing himself/herself to next level. My client also offers competitive package and career development plan for their employees.
- Manage and serve as the primary point of contact with study sites and vendors.
- Ensure clinical projects are effectively executed and completed within the budget and timelines.
- Ensure clinical studies are conducted in compliance with related guidelines and regulatory requirements.
- Create and maintain clinical project files according to regulatory requirements and ensure study documentation meets FDA/GCP/ICH guidelines.
- Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
- Minimum master degree (major in nursing, pharmacy or other science-related background)
- Minimum 5 years experience in clinical research in healthcare, pharmaceutical and/or CRO industry or minimum 3 years direct experience in clinical project planning, coordination and management, with multi-national trial exposure.
- Good command of English verbally and in writing.
- Knowledge of clinical research concepts, practices, and FDA regulations and ICH/GCP guidelines.
- Competitive salary package.
- Positive internal culture.