Summary:
Provides?oversight?of?all?electronic?and/or?paper?Trial?Master?File?(TMF)?management?activities?for?assigned?projects?and/or?programs?from?award?to?final?transfer.?Supports?and?oversees?successful?completion?of?all?TMF?scoped?deliverables?including?TMF?Plan?development,?TMF?set-up,?monitoring?document?submissions?and?processing,?oversight?and?coordination?of?Quality?Control?(QC)?processes,?internal?and?external?audit?representation,?TMF?shipments,?etc.、
Essential?Functions:
1.Attends?Trusted?Process?meetings?such?as?Kick-Off,?Quick?Start?Camps,?Jump?Start?Camps,?Quality?Finish?Camps,?etc.?as?TMF?Subject?Matter?Expert?(SME)?and?successfully?communicates?and?presents?TMF?status?updates?and?seeks?relevant?information?to?drive?the?execution/delivery?of?the?TMF.
2.Leads?the?TMF?set-up?and?structure,?configures?completeness?reports?and?sponsor/project?specific?completeness?reports,?and?develops?the?list?of?expected?documents?and?the?gap?analysis.
3.Actively?involved?in?ProjectPoint?including?Gateway?set-up?and?training?for?the?Project?Team,?as?applicable.
4.Collaborates?with?the?Project?Lead?(PL)?and?Functional?Leads?(FL)?to?ensure?TMF?documentation?is?submitted?and?published?in?a?timely?manner?and?with?high?quality?in?order?to?maintain?the?TMF?in?an?audit-ready?state.?Develops?plans?to?increase?compliance?and?follows?up?on?non-compliance,?if?applicable.
5.Attends?internal?project?team?and?sponsor?teleconferences?and?face-to-face?meetings?as?TMF?SME?as?applicable?to?the?project/program.
6.Designs?and/or?delivers?study?specific?TMF?training?in?various?formats?via?teleconference,?video?conference,?and/or?in?person.
7.Generates?and?provides?Completeness?Reports?and?inspection?readiness?metrics?to?the?Project?Team.
8.Participates?in?audits/inspections?and?prepares?for?audits?to?ensure?audit-readiness?for?the?TMF.
9.Provides?regular?feedback/training?to?the?Project?Team?on?TMF?health/status.
10.Identifies?TMF?best?practices?and?leads/participates?in?TMF?process?improvement?initiatives.
11.Represents?the?TMF?during?Quality?Finish?Meetings,?provides?guidance?to?the?Project?Team?and?Regulatory?Records?Team?on?perfoming?the?final?QC/Completeness?Review,?and?oversees?the?TMF?Shipment/Archival.
12.Ensures?thorough?understanding?of?contracted?scope,?timeline,?and?budget?for?the?TMF.?Works?with?department?management?to?monitor?TMF?team?performance?to?the?budget?and?documents?any?out-of-scope?work?in?Change?Notification?Form/Change?Orders?as?required.
Other?Responsibilities:
Performs?other?work-related?duties?as?assigned.?Minimal?travel?may?be?required?(up?to?25%)
Requirements:
BA/BS?in?the?life?sciences,?business?administration,?or?related?discipline;?or?equivalent?combination?of?education?and?experience.?Moderate?experience?in?a?Contract?Research?Organization?or?related?field.?Experience?with?leading/co-leading?studies?from?award?into?maintenance?on?a?Global?scale.?Proficiency?in?Microsoft?Office?Suite?(Word,?Excel,?and?PowerPoint),?email,?and?voicemail.?Above?average?attention?to?detail,?accuracy,?and?organizational,?interpersonal,?and?team-oriented?skills.?Ability?to?perform?several?tasks?simultaneously?to?meet?deadlines.