工作職責(zé):Primary?Responsibilities??General? Ensure?that?all?data?components?are?conducted?in?compliance?with?GCP,?relevant?SOPs,?and?regulatory?requirements.? Ensures?Conformance?to?Pfizer?Data?Standards.? Actively?participates?in?monthly?project?review?meetings.? May?participate?in?Therapeutic?Area?(TA)?specific?process?improvement?initiatives.Hands-on?data?management?responsibilities?(Data?Manager):? Create?and?implement?the?Data?Management?Plans?(DMP)?to?ensure?data?completeness?and?accuracy.? Set-up?and?test?data?review?listings?to?verify?the?quality?and?completeness?of?data?as?specified?in?DMP.? Ensure?timely?set-up?of?clinical?data?acquisition?and?management?tools?and?data?validation.?? Maintain?study?tracking?to?ensure?timely?CRF?retrieval,?data?entry?and?data?cleaning?activities.? Perform?data?cleaning?activities?including?discrepancy?management?(review?of?errors?from?electronic?checks)?and?review?of?data?listings?to?verify?quality?and?completeness?of?data.? Ensure?integrity?of?clinical?data?and?update?database?by?issuing?and?resolving?DCFs?as?necessary.? Reconcile?the?patient?database?with?the?Serious?Adverse?Event?database.? Document?all?efforts?of?data?management?and?file?all?responsible?documents.Study?management?responsibilities?(Lead?Data?Manager):? The?single?point?of?contact?for?study?team?on?data?management? Accountable?for?the?implementation?of?all?data?activities?for?the?responsible?studies.? Review?protocols?to?ensure?the?data?collection,?database?and?reporting?requirements?can?be?met?and?are?standardized? Provide?technical?oversight,?guidance?and?coordination?for?all?the?data?management?activities? Produce?and?track?metrics?as?a?tool?to?ensure?that?data?management?deliverables?are?on?target.? Implement?and?promote?the?use?of?consistent,?efficient?and?quality?processes?to?meet?timelines?and?deliverables.???? Assist?in?the?development?and?implementation?of?new?TA?clinical?data?standards? Ensure?clear?and?timely?communication?with?study?team?members?to?enable?continuous?improvements?during?the?study?? Proactively?plan,?assess?workload,?and?prioritize?activities?to?ensure?study?timelines?are?met? Ensure?lessons?learnt?during?the?course?of?the?study?are?documented?and?shared?with?other?study?teams?to?facilitate?cross-study?learning.Project?management?responsibilities?(Project?Data?Management?Lead):? Work?directly?with?CROSL/CPM?as?point?of?contact?for?data?management?at?project?level:– Ensure?sufficient?and?qualified?study?level?resources?and?cost?effectiveness?– Ensure?milestones?achieved?and?project?plans?consistent?across?studies– Ensure?the?quality?standards?and?consistency?of?practices?(especially?safety?data,?i.e.?SAEs)?across?studies?and?submission?readiness– Ensure?that?data?activities?are?conducted?in?compliance?with?SOPs?and?relevant?regulatory?requirements;?– Serve?as?point?of?contact?for?internal?and?external?audits?and?regulatory?authorities?of?data?management?related?processes?and?activities– Ensure?conformance?to?TA?Data?Standards?by?using?data?management?expertise?including?new?data?standard?creation?and?maintenance? Develop?and?maintain?TA?specific?knowledge?base?within?data?management?practice? Coordinate?experiences?(PDLs,?PPLs?or?other?related?functional?lines)?sharing?across?studies,?e.g.?best?practices,?lessons?learnt,?metrics?of?trends?analysis,?etc.?? Help?CROSLs/CPMs?to?have?direct?access?to?the?most?relevant?biometrics?expertise?at?anytime? Partner?with?PPL?to?ensure?full?biometrics?availability?at?anytime?during?different?study?stages? Partner?with?CROSLs/CPMs?,PPLs?and?Pfizer/AP?front-end?lines?to?promote?the?increased?efficient?use?of?data?collection?methods?(CRF?and?non-CRF?data?collection?instruments,?site?training,?vendor?selection)?and?technologies?in?clinical?trials?at?project?level任職資格:Technical?Skill?Requirements? Demonstrated?knowledge?of?clinical?development?process?including?knowledge?and?understanding?of?the?principles?of?GCP? Demonstrated?knowledge?of?data?management?processes?and?principles?in?area?of?responsibility.? Works?independently,?receives?instruction?primarily?on?unusual?situations? Ability?to?organize?tasks,?time?and?priorities;?ability?to?multi-task? Ability?to?communicate?effectively?and?appropriately?with?internal?&?external?stakeholders,?locally?and?globally? Ability?to?work?in?ambiguous?situations?within?teams?to?identify?and?articulate?complex?problems? Demonstrated?knowledge?of?clinical?development?and?regulatory?submission?processes?and?requirements.?? Knowledge/proficiency/understanding?of?technologies?to?support?data?acquisition,?computerization?and?data?validation,?computer?systems?life?cycle?technology? Strong?understanding?of?the?state-of-the-art?technologies?to?evaluate?and?leverage?them?into?improved?business?processes?for?worldwide?deployment?and?adoption.Qualifications?(i.e.,?preferred?education,?experience,?attributes)? ?Bachelor?degree?or?equivalent?in?a?natural/medical?science,?data?management?or?related?discipline.?Preferred?Additional?Experience? Working?knowledge?of?clinical?development?process,?understanding?concepts?of?Phase?I-IV?and?principles?of?study?design? Previous?experience?within?a?data?management?role,?understanding?key?processes?and?principles?associated?with?role?including?CRF?design,?database?set-up,?edit?check?specification,?DMPs?and?data?cleaning?activities? Knowledge?of?clinical?trial?database?and?its?applications?? Knowledge?of?Windows?Environment?and?its?applications?(Word,?Excel,?PowerPoint,?Project,?etc.)