June Chen Email & Phone Number

Taipei

•Manage sites in Taiwan and Australia, addressing protocol-related inquiries, overseeing study supplies, and conducting central monitoring visits, spanned from Pre-study Initiation, Site Initiation Visits (SIV), Database Lock, and Closing Visits.•Identify and escalate protocol and Case Report Form (CRF) discrepancies, collaborating with the Clinical Trial Manager and Medical Monitor to ensure timely resolution and adequate training for site staff.•Streamline site payment reconciliation, clarifying payments with stakeholders•Implement Institutional Review Board (IRB)/Ethics Committee (EC) submissions and start-up essential document preparation in Taiwan and Australia.•Investigation Product (IP) accountability, dispensation, and compliance at the site.

Taiwan

· Project Initiation Management . Ensure tools and systems are set-up and ready for use by the project teams according to SOPs and ensure system interfaces are functioning . Provide initial resource plan. · Responsible for study reporting and analysis and for highlighting issues for project team. Ensures system data or compliance issues are followed up and solved as needed. · Responsible for drafting a consistent coherent project management plan, including coordinated planning of project activities and input from the different functions (scope, CIS, risk plan, quality plan, communication plan, schedule, procurement plan, and resource plan). · Assure study supplies are delivered as required and according to contract obligation · Project Financial Management. Reviewing and processing pass through cost invoicing, marking any inconsistencies and wrong bookings for PL review. · Project Closure Management. Ensure all systems are up to date with final information and all issues are closed. Collaborates with team on ensuring that documents archived and final work handed-over to the sponsor.

Taiwan

Deliver technical and clinical information to surgeons and healthcare professions in medical center and maintain relationship with key customersPrioritize and maintain accurate project progress through coordinate case reports from sales representatives Analyze market trends and competitions to deliver effective presentations to customers to increase awareness of the company's products Coordinate with Asia-Pacific clinical manager and other functional teams in symposia and continuing education seminars

Execute potential subject recruitment and pre-selection of subjects for eligibilityEnsure studies are prepared and progressed as standard protocols follow the current regulationConduct IRB correspondence Perform projects filing, submitting, and retrieving annul reportsPerform statistical analysis and participated in project meetingsEnsure accuracy and completion of ICF and essential documents for paper and electronic files; perform document scanning when applicable

Neuroscinece

Bachelor'S Degree, Biomedical Science