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研究者發(fā)起試驗(yàn)項(xiàng)目管理專員

輝瑞(中國)研究開發(fā)有限公司
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工作性質(zhì): 全職 更新日期: 該職位已過期
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工資待遇: 面議 招聘人數(shù): 若干人
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崗位介紹:?The?IRC?Associate?provides?primary?operational?support?to?various?programs?within?Medical?Affairs?Platform?Strategy?(MAPS)?group?which?including?but?not?limited?to?Investigator?Initiated?Research?(IIR),?Clinical?Research?and?Collaboration?(CRC),?Compound?Transfer?Program?(CTP),?Clinical?Data?Request?(CTD),?Independent?Grants?for?Learning?&?Change?(IGLC)?and?Publications?Programs.??The?major?responsibilities?including?but?not?limited?to:??Maintaining?systems,?Share?Point?sites?and?databases?used?for?program?management;?Receive,?generate?and?distribute?program?related?documents?&?report?according?corresponding?Pfizer?SOPs?and?guidelines;?Process??eligibility?check,?finance?transactions?and?drug?distribution?as?requested.?The?IRC?Associate?will?work?closely?with?program?managers?with?necessary?communication?and?coordination?to?ensure?efficient?program?process?and?compliance.???崗位職責(zé):??The?support?area?of?Non-Pfizer?sponsored?research?grants??including?but?not?limited?to:??????Reviews?incoming?Non-Pfizer?sponsored?research?requests?and?documents?for?accuracy?and?completeness;?enters?requests?into?research?management?system?and?prepares?required?correspondence?to?external?requestors?&?Pfizer?colleagues,?such?communications?to?investigator,?Review?Committee?members,?Field?Based?Medical,?Regional,?or?PCO?colleagues.????????Manages?distribution?of?study?related?documentation,?preparation?of?meeting?agendas,?and?assists?with?scheduling?review?meetings?or?due?diligence?review?for?Non-Pfizer?sponsored?research?programs;?contacts?requestors?for?missing?or?requested?documentation,?as?directed?by?CRC?Liaisons?and?/or?IIR?Program?Managers.??????Manages?financial?transactional?details?as?well?as?drug?supply?requests?(i.e.?generating?drug?supply?forms)?based?upon?executed?contract?and?study?milestones;?works?with?IIR?Program?Managers?/?CRC?Liaisons?and?Pharmaceutical?Sciences?Supply?Chain?Coordinators?to?ensure?clinical?supply?forecasts?are?up-to-date?and?supplies?are?available?as?required.??????Assists?regular?study?oversight?activities?such?as?generation?of?requests?to?investigators?for?enrollment?sweeps?and?study?progress?updates,?forwards?documents?to?appropriate?reviewer?and?keep?the?research?management?system?updated.??????Maintain?expertise?of?Non-Pfizer?sponsored?research?process?and?policy,?assists?PCO?colleagues?who?are?completing?the?submissions?in?research?management?system?to?address?missing?information?and?ensures?compliance?to?Pfizer’s?policies?on?Safety?Reporting,?FCPA,?HCP?and?Privacy?(as?required).??????Uploads?final?deliverables?received?from?requestors?and?closes?completed?studies?in?the?research?management?systems.??????Assists?CRC?Liaisons?or?IIR?Program?Managers?with?status?report,?queries?and?other?logistic?support?as?required.???????Contributes?to?process?and?technology?improvement?projects?within?areas?of?responsibility,?as?requested.???The?support?areas?of??IGLC?program?including?not?limited?to:??????Perform?compliance?check?of?organizations?against?internal?and?external?watch?lists?(such?as?OIG);?check?promotional?speakers?(EZspeak,?iMAS);?review?potential?external?review?panel??nominees?against?multiple?database?(e.g.,?EZspeak,?CAL);?verify?requestor?accreditations?(e.g.,?ensure?accredited?org?is?‘requesting?org’?for?grant?request;?obtain?supporting?documentation?when?accreditation?is?activity-based).??????Obtain?IRB?approval/exemption?documentation?for?Quality?Improvement?grants?(when?applicable);?check?PI?against?multiple?databases?D&I?Research?(e.g.,?CAL,?INSPIIRE?for?CRC,?and?other?external?references).??????Asist?financial?payments?for?all?IGLC?programs,?identifies?existing,?valid?vendor?IDs?or?creates?them?when?necessary?in?Ariba/SAP.?Ensure?current?W8/W9?form?obtained?and?completed?appropriately.?Resolves?payment?process?issues,?initiates?reissuance?for?lost?checks,?resolves?technical?issues?(SAP,?GMS),?and?follows?up?with?GFSS?as?necessary.??????Maintain?and?track?grant?management?system?access?for?both?internal?and?external?individuals.?For?Pfizer?internal?individuals,?ensure?required?training?is?appropriately?assigned?in?P2L.?For?external?individuals?(such?as?ERP?member,?RFP?partnerships),?obtain?user?access?agreement?as?needed.??????Periodically?pull?program?related?information?form?grant?management?system?and?posted?on?Pfizer?home?page?and?internal?Share?Point?site?using?populated?templets?and?formats?to?meet?stakeholder?needs.??????Participates?in?any?grant?monitoring?activities?(e.g.,?follow-up?on?milestone?data,?outcomes?data).?Refreshes?reports;?distributes?to?specific?DLs?and/or?posts?to?IGLC?SharePoint/intranet?per?set?schedule.??????Promotes?consistency?and?standards?with?internal?processes?and?deliverables;?performs?QC?reviews?according?to?relevant?SOPs?and?job?aides;?assists?in?training?others?and?maintaining?training?documents;?assists?in?metrics?compilation?and?raises?potential?compliance?risks.??????Assists?ILGC?manager?in?ensuring?the?compliance?of?all?IGLC?systems?and?processes?with?internal?and?external?compliance?requirements,?policies,?and?guidelines;?provides?support?during?audits.??????Coordinates?with?Pfizer?country?offices?and?regional?colleagues?to?provide?operational?support?as?required?to?execute?IGLC?global?strategic?initiatives.????The?support?area?of?publication?including?but?not?limited?to:??????Support?publication?activities?by?completing?watch?list?checks?and?related?forms,?in?relation?to?determining?if?external?manuscript?authors?are?included?on?any?debarment?watch?lists,?as?per?publication?SOP??????Responsible?for?providing?access?to?DataVision?(DV)?to?internal?and?external?stakeholders?by?ensuring?that?appropriate?training?has?been?completed?for?the?requested?role???????In?partnership?with?the?Publication?Specialists?and?Publication?Manager?of?Operations,?support?the?management?of?monthly?invoice?processing?from?publication?vendors?(~200?invoices/month),?including?reconciliation?of?records?in?DataVision?(DV)?and?confirmation?of?receipt?of?deliverables?prior?to?invoice?payments.?????The?support?area?of?INSPIIRE?system?admin?&?helpdesk?service?including?but?not?limited?to:??????Serve?as?INSPIIRE?systems?administer?to?manage?user?access,?project?team?assignment?and?general?oversight?INSPIIRE?systems?(INSPIIRE?external?Portal?website?and?internal?workflow/database?management?system),?resolve?simply?to?moderate?complex?system?issues.???????Handles?helpdesk?requests?from?external?and?internal?stakeholders,?develop?FAQ?and?guidance?material?to?improve?user?experience?and?satisfaction.??????Develops?and?delivers?training?materials?regarding?system?functionality,?internal?workflow?and?document?management,?provides?INSPIIRE?customer?database?stewardship?in?cooperation?with?the?INSPIIRE?system?support?team.??????Periodically?pulls?data?from?the?INSPIIRE?system?to?provide?continuous?monitoring?of?IIR/CTP/CRC?program,?apply?advance?data?analysis?and?reporting?tools?to?identify?non-compliance?and?CAPA?action?items,?for?example,?data?accuracy,?completeness?and/or?discrepant?(with?source?data)?information?and/or?documentations?in?the?system?according?applicable?Pfizer?policies,?SOPs?and?local?WIs/Guidelines.????????Maintain?the?helpdesk?mailbox,?creates?and?distribute?standardized?or?ad?hoc?report?as?scheduled?or?based?upon?request.??Summarize?action?items?of?business?reports?and?communicates?with?responsible?grants?management?team?appropriately,?follow?up?with?finding?resolutions?and?corrective?actions.?Records?findings?and?follow?up?correspondences?in?centralized?area?for?tracking?and?reporting?purposes.??????Works?with?the?INSPIIRE?support?team?as?an?SME?for?testing?and?developing?improvements?to?the?program?management?portal?/?system.?Contributes?to?process?and?business?technology?improvement?projects?within?areas?of?responsibility,?as?requested.???崗位要求:?Bachelor’s?degree?(BA,?BS)?required?with?preference?for?a?focus?in?science,?healthcare?or?related?field.??Good?written?and?oral?English?skills,?Japanese?fluency?highly?desired.??Operational?experience?in?clinical?trial?management,?educational?grants?or?healthcare?industry?(pharmaceuticals,?life?sciences,?and?medical).??Knowledge?of?IT?systems/software?for?database?maintenance?and?document?management.??Demonstrated?effectiveness?working?in?a?multidisciplinary,?matrix?team?situation,?and?demonstrated?ability?to?manage?change?and?diversity.??Good?understanding?of?multiple?disciplines?(e.g.,?Healthcare?Compliance?Law,?Regulatory,?Drug?Supply,?Clinical?Study,?Medical?Affairs,?Medical?Educational?Grant,?Publication?development,?Project?and?Financial?Management)?and?organizations?(e.g.,?Pfizer?Country?Offices?and?Regions)??Experience?with?various?Pfizer?processes/systems/functions:?MAPP?(FCPA),?Ariba?SAP?reporting?strongly?preferred.??Developed?customer?service?skills?and?team?work?spirit.

On?October?31,?2005,?Pfizer?announced?the?official?opening?of?China?Research?and?Development?Center?(CRDC)?in?Shanghai.?Pfizer?Global?Research?and?Development’s?Center?is?mainly?engaged?in?drug?development?activities.?Much?of?the?facilitys?capacity?is?devoted?to?the?study?design,?data?management?and?statistical?analysis?of?global?phase?I-IV?clinical?trials,?as?well?as?the?clinical?study?report?process.?In?addition,?CRDC?is?a?part?of?Pfizer?global?Safety?and?Risk?Management?and?covers?the?functions?of?safety?data?processing?and?assessment.?The?center?also?trains?Pfizer?employees?in?China?and?throughout?the?Asia?region?in?internationally?recognized?Good?Clinical?Practice?standards.
輝瑞公司于2005年10月31日宣布輝瑞中國研發(fā)中心正式在上海揭幕。輝瑞中國研發(fā)中心主要為全球輝瑞藥物開發(fā)提供支持工作。大部分的功能是圍繞在I-IV期臨床試驗(yàn)研究設(shè)計(jì)、數(shù)據(jù)管理和生物統(tǒng)計(jì)分析、以及臨床試驗(yàn)報(bào)告的部分準(zhǔn)備工作。此外,該中心是輝瑞全球安全和風(fēng)險(xiǎn)管理部的一個(gè)分支,負(fù)責(zé)安全數(shù)據(jù)處理和評估工作。研發(fā)中心還將為輝瑞公司在中國及亞洲的其它運(yùn)營部門的員工提供國際標(biāo)準(zhǔn)的臨床試驗(yàn)管理規(guī)范(GCP)的技術(shù)培訓(xùn)。
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