- Extensive knowledge in clinical information system, operational procedures, pharmacovigilance, clinical trial data management and project management.
- Experienced in contract negotiation, CDA, MSA, RFI and RFP.
- Leading implementation of validated business application projects, including preparing validation documents, e.g. project plan, functional requirements and system architecture plan and system IQ/OQ/PQ.
- Using SDLC in development of enterprise business infrastructure design, develop, implementation, administration and production support.
- Works side by side with business partners in determining requirements, preparing validation documentations and testing plan to achieve strategic goal and compliance.
- Preparation and review of operational documentations, such as, SOPs and WIs.
- Computer system validation and system or vendor audit for compliance with regulatory requirements.
- Familiar with clinical study setup, eCRF design, Managing Global Objects, DMP, medical coding, 21 CFR Part 11 and FDA Guideline, SAS in statistic analysis.
- Experience in medicinal chemistry research and development in pharmaceutical companies.
Director of Clinical Analyst
- Partner with Oracle OLS in business development for CDMS and Pharmacovigilance applications in APAC region used in clinical trials and drug AE reporting system.
- Working with clinical trial industry partners and regulatory agent on the use of Oracle Clinical, RDC, AERS and Argus to meet the compliance requirements and ICH GCP standard.
- Leading clients’ validated implementation projects for OLS suite of Applications.
- Training/supporting clients in the use of Oracle Clinical on study setup, eCRF design, global library, and validation/derivation and discrepancy management procedures.
- Successfully leading/participating in over 10 projects of system implementation in APAC region.
Senior Clinical Analyst
- Working with business partners in supporting global/US clinical trials.
- Designing functional requirements and writing/modifying requirement specifications for clinical data management system.
- Leading and managing company’s core business application and supporting/helping the use of Oracle Clinical functionalities in clinical trial studies.
- Technical leader for a successful major Oracle Clinical upgrade and data migration project.
- Designed and programmed a PART 11 compliant Audit Management System based on TrackWise for QA department, used for standardizing audit procedures, tracking observations, CAPA and reporting purpose, as well as TrackWise configuration and administration.
- Managing and supporting global pharmacovigilance department users in the use of adverse event reporting system for regulatory submission.
- Implemented and validated Oracle Adverse Event Reporting System (AERS).
- Using E2B for pharmacovigilance data Migration and Consolidation for acquired drugs from different companies in different countries.
- Maintaining company pharmacovigilance data repository and facilitate regulatory reporting.
- Maintain and update medical/drug dictionaries, MedDRA and WHODrug.