Jill Funk
Associate Director, Clinical Quality Assurance, Data Management & Data Integrity @Eisai US
Signup · Get unlimited contacts
WORK HISTORY
Associate Director, Clinical Quality Assurance, Data Management & Data Integrity @Eisai US
Lead Quality oversight of DM activities including end to end study data flow starting from secure dataacquisition; SDTM/ADAM to CSR and submission.• QA oversight of validation & quality control of activities, including but not limited to clinical study databases build, database lock process, SAS/SDTM programming, regulatory submission.• Manage health authority inspection preparation activities and provide leadership and oversight duringinspections.• Compile and analyze audit metrics to communicate trends to business group.• Lead and Perform Data Integrity & Access Governance (DIAG) audits as needed.
EDUCATION
Rutgers University
Bachelor's degree, Psychology
ABOUT JILL FUNK
Quality-driven Data Management Leader with 25+ years of pharma/med device/diagnostic/clinical research exp: • 20 years DM experience (increasing responsibility including line/department management/building)• 5+ years QA GCP Auditor/Project Manager experienceTechnologies: Medidata (Rave EDC, CTMS, RCM, TSDV, eCOA, RTSM, Site Payments), Oracle InForm, Veeva VaultStudy Start-Up (including protocol), Conduct (ongoing data cleaning), Database Lock, TLFs, CSR, and SubmissionPhase I - IV multi-center global clinical trials in major therapeutic areas, including:• Cardiovascular (Phase Pivotal/Mega trial + Submission)• Oncology (Phases + Pivotal + Submission) • CNS• Transplantation • Immunology Both outsourced and in-house DM operating models for studies utilizing EDC:• CRO/ARO/vendor oversight/management• Timeline/risk assessment/management• RFI/RFP/Scope of Work/Contract/RACI• Budget/Change Order/Invoice approvals• Vendor audit/Qualification & MSA/SLAManagement of direct reports/dept, both remote/office-based staff, including:• Short-term & long-term departmental initiatives to optimize DM dept• Negotiate multi-year multi-million dollar deal for EDC/CTMS vendor• Senior & Lead CDMs, Medical Coding Group, Medical Data Reviewer• Resource utilization/allocation/strategy and workload management• Issue escalation/resolution• KPI/Goal/Objective setting• Performance Assessments• Professional Development• Interviewing/hiring/onboarding/training• Timesheet/Expense Report/PTO approvalsContinuous Process Improvement, including:• Lean Six Sigma Yellow Belt certification in 2015 (through Daiichi Sankyo Inc)• Chair/Co-Chair of Standards Committee (CRFs, edit checks, CCGs, datasets)• Chair of EDC/CTMS Vendor Assessment/Selection/Implementation Committee• Database Lock Task Force (DM rep)• Global Standards Library and Standards Governance (CDISC CDASH & SDTM)• Global Protocol Template Working Group (DM rep)• Author/reviewer of Data Management SOPs/SOIs/WIs/Templates/FormsSuccessful NDA (and multiple countries) regulatory submissions, including:• Oversee preparation of submission packages, including pivotal/legacy studies:• SDTM datasets/aCRF/Define.xml/CRF pdfs/SDRG (Study Data Reviewers Guide)• Inspection Readiness Task Force• Mock inspections• On-site FDA Sponsor Inspections• DM respondent to any data-related FDA/Regulatory Agency inquiries
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.