Company Confidential is looking for new potential candidates to fill in for CLINICAL RESEARCH MANAGER (Clinical Trial Projects) @ Pharma / Hospital/ Academy position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- Management of all clinical sites from start up to close-out.
- Lead the Clinical Research Team (Clinical Trial) to achieve key performance
- Work on Management Proposals for new projects by conducting scientific and feasibility review of new projects
- Plan, manage and review research projects’ execution to ensure they are within approved budget, resources & timeline.
- Develop new study protocols, research proposals, research budget and to review projects for cost impact and risks for unplanned deviations.
- Prepare and manage submissions for the EC (Ethics) & RA (MOH/Country) submissions
- Manage and follow up IND submissions, Orphan Drug applications and maintenance of regulatory and ethics approval
- Identify, collaborate and manage project progress with external contract research organization, collaborators and project managers to new project start-ups and support research project for product development.
- Internal collaboration including agreements review with Legal Department, study documents and drug dossier with Regulatory Affairs, drug safety issues with Clinical Research Physician and new research findings and technical responses to support Marketing team on products of interest.
- External collaboration with regulatory consultants e.g. Europe CROs / agents / representatives
- Attend meetings to secure successful regulatory applications such as Orphan Drug Designation and Pre-IND meetings with US FDA.
- PHD/Master/Degree in Medical/Bio/Pharma or related disciplines.
- Preferably 4-5 years of experience in conducting research for clinical trial projects & currently at Managerial/Supervisory level.
- Similar experience in Pharmaceutical / Hospital / Academy fields.
- Good communication + leadership skills.
- Permanent vacancy. Flexible work location - Selangor / Penang / Perak
How To Apply
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