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Director Of Clinical Analyst Resume

SUMMARY

  • 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.

PROFESSIONAL EXPERIENCE

Director of Clinical Analyst

Confidential

Responsibilities:

  • 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

Confidential

Responsibilities:

  • 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.

DBA Manager

Confidential

Responsibilities:

  • 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.

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