Chia-I Lee Email and Phone Number

FSP to Johnson & Johnson Innovative Medicine - Global Clinical Operations

• Track & report monitoring KPIs from CTMS - MV/co-MV, SSV, SIV, COV, contact visit.• Prepare project-stress indicator metrics and IBU metrics to ensure overall project efficiency and risk management.• Operate EDC, Viedoc & IRTON Systems to report trial progress - SDV Rate, Data Entry Rate, Protocol Deviations, Reporting of SAE & SUSAR.• Ensure TMF QCs are completed as per TMF Plan & provide TMF report.• Perform ongoing maintenance & timely reconciliation of systems - CTMS, OA, eTMF, TEL, SharePoint.• Track training compliance & ensure timely completion of project teams; perform reconciliation with IT administrators as necessary.• Support audits & regulatory inspections.• Manage submission & reconciliation of investigator payments, vendor & site invoices, financial reimbursement of CRAs.• Support submission of contract / agreement of sites & vendors, follow up on gaps proactively - CDA, CTA, MSA, WO etc.• Schedule & participate Investigator Meetings, SMC meetings, CRA Trainings, Internal & Sponsor Meetings; preparation & distribution of meeting materials & minutes.• Develop & distribute study plans, project tools & trackers - ADI Log, Q&A Log, Contact List, Training Grid.• Facilitate prompt & efficient communication with sponsors, country team (CPM, CRA and CTA), cross functional teams & third parties/vendors.• Engage in communication & oversight of vendors - central lab, clinical trial logistic, supplier of laboratory consumables.• Prepare Newsletters to keep project team & sites informed of significant updates.• Mentor & guide in-house CRA, CTA & junior GPA as required.• Track liquidation of project members against WO to align with study budget & allocated FTEs.• Work alongside PMs & PDs to manage project contractual deliverables in terms of project milestone, project quality & sponsor expectations.• Manage & coordinate the conduct of clinical trials from study start-up to close-out in compliance with ICH-GCP, regulations & SOPs.