Eileen Cho Email & Phone Number

Irvine, Ca, Us

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Certified Compliance & Ethics Professional (CCEP)

Thousand Oaks, Ca, Us

• Develop drug development, clinical research (GCP), regulatory (safety, risk management) and healthcare compliance training (ILT, eLearning, blending learning activities).• Provide new hired orientation program for staff in the Asia, Japan and Latin America countries.• Design and deliver training on global SOPs, clinical trial management system, Clinical Drug Supply System and Electronic Data Capture tool.• Engaged in process improvement project swith aims to improve efficiency, quality, cost and cycle time of clinical trial and regulatory submission processes.• Provide organization restructuring training, resiliency training and performance improvement consultation.• Identify gaps and defienciency in SOPs and business processes and feedback to document owner for revision.• Serve in the GCP Adice Forum to provide best practice and/or advice to questions related to GCP and regulations submitted globally.• Determine appropriate training methodologies, assess training needs, and evaluate training effectiveness with sr. management and stakeholders.

Implement learning management programs to ensure training compliance according to training matrix. Develop, implement, and maintain a document management system.Develop Global Clinical Research SOPs, related standard documents, and training manuals. Chair sub-teams of the Global Clinical Process Committee and the Global SOP Committee.Consult with the clinical teams in the area of . Liaise cross functional representatives to support clinical teams on expanding ICH-GCP, clinical research ethics, quality and regulatory compliance as well as therapeutic area knowledge base related to clinical trial design and conduct.Carry out special projects related to the user requirement definition, validation, implementation, training, monitoring, and/or auditing for new technology and computerized systems used in clinical studies.

Indianapolis, Indiana, Us

Lead a cross functional integration team to design and implement one consistent SOP document structure for the entire company Develop and implement an integrated Quality Management System and compliance program using the ISO 9001 2000 concept and 6 Sigma methodologyPerform annual risk model analysis for the Executive Management CommitteeAssess GCP audit results (trend, gap and root cause analysis) for internal supporting functions and external collaboratorsDevelop and implement Medical SOPs and guidance for the CFR, GCP, computer system validation, Part 11 and ICH guidelinesEstablish QC processes to warrant the integrity and quality of clinical trial dataLead a matrix team for the excellency of product development, regulatory document review and submissionIntegrate Japan’s operation and global processes for simultaneous submission and early launchShare best practice and build a quality culture in the business plan and accountability model

Indianapolis, Indiana, Us

Lead the process improvement project for area affiliates to meet corporate and Clinical objectivesCoordinate system validation, QC and GCP issue resolutionFeedback local regulatory requirements to global study teams for their assembly of the submission dossier Interact with regulatory authorities to reach mutual agreement on interpretation of ICH guidelinesCoach and mentor affiliate quality coordinatorsProvide medical training strategy for 13 affiliates in Asia Pacific regionOffer GCP training certification program at the startup meetings, to IRBs and academic institutionsProvide “Center of Excellence” technical consultation service to nurture and develop experienced medical personnelDevelop regional training strategies and supervise local resources for decentralized training activities for best results

Indianapolis, Indiana, Us

Supervise the Gemzar* product team for compassionate trials, post-marketing trials (phase IIIb – IV)Plan study and co-monitor with CRO and Cooperative groupEnsure that clinical trial documentation satisfies the requirements of regulatory authoritiesInvestigator site qualification and contract negotiationApprove CIB, protocol (amendment) and monitoring planLiaise publication plans and product promotional informationCapacity management, staff training, performance appraisal and career developmentNDA submission of Gemzar* for the treatment of pancreas cancerCoordinate global registration trials on lung cancer in EU, Asia and US.

M.Sc, Pharmacology And Toxicology

Bs, Pharmacy