Regional Clinical Project Manager
Location: Taipei, Taiwan
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts
- Assesses the operational feasibility of studies and recommends execution and risk mitigation plans
- Co-monitors as needed
- Develops and tracks study timelines, budget, and quality metrics
- Ensures appropriate clinical resources are available for the clinical project
- Ensures GCP and regulatory compliance is maintained
- Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature
- Manages clinical projects from concept through clinical study report completion
- Oversees clinical research study conduct
- Manages, mentors, and develops direct reports
- Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources
- Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts
- Participates in meetings with investigative sites, key opinion leaders and consultants as needed
- Plays a part in the analysis, summary, and reporting of clinical data through the course of the study
- Aides in the training and development of all clinical staff members
- Performs other duties as assigned
- Proactively identifies and resolves issues, and participates in process improvement initiatives as required
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants
- Reviews and approves invoices from study vendors, investigators, consultants, etc.
- Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken
- Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks
- University degree in Science/Biology/Biochemistry/Chemistry or related fields.
- Minimum 8 years of relevant experience in Clinical
To apply, please email CV to c.insung(a)realstaffing.com, or call +65 6871 4700 for further information.
Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)
Award winner of:
International Recruitment Company of the Year by Recruitment International 2016
Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
Best Overseas Operation by Global Recruiters 2017
Highly Commended for Best Large Recruitment Business 2017