Position?Purpose:
1.?Main?contact?person?to?support?country?study?team?to?communicate?with?global?PTDS,?local?PT?or?third?party?vendor?to?ensure?proper?management?of?clinical?supply?from?order?to?destruction?in?accordance?with?ICH-GCP,?local?GCP,?GMP,?SOPs,?regulations?and?requirements.
2.?Provide?user?requirement?specification?to?local?PT?for?third?party?vendor?selection,
evaluation?and?inspection,?if?apply.
Responsibilities:?Clinical?Supply?Management
??Support?country?study?team?to?coordinate?local?PT?and?global?PTDS?to?ensure?a?smooth?clinical?study?medication?importation?as?per?study?timeline.?Track?and?document?goods?receipt?status?at?local?depot.
??Ensure?that?sensitive,?potential?unblinding,?IMP?documentation?that?is?required?by?local?customs?for?importation?purposes?is?not?shared?with?the?Local?Study?Teams?in?CCO?China,?nor?investigational?site?staff.?Also?ensure?that?these?documents?are?not?archived?in?a?location?that?is?accessible?by?local?CCO?study?teams.
??Coordinate?with?local?PT?and?country?study?team?to?make?sure?the?clinical?study?medication?to?be?dispatched?to?the?clinical?study?site?per?request.?Track?and?document?dispatch?information.
??Support?country?study?team?to?purchase?the?commercial?drug?for?clinical?study?use?and?coordinate?with?local?PT?to?conduct?additional?labeling?upon?request?within?required?timeline.
??Support?country?study?team?to?coordinate?with?local?PT?in?additional?labeling?of?use-by
date?extension?for?clinical?study?medication?upon?request?within?required?timeline.
??Coordinate?with?local?PT?and?country?study?team?for?clinical?service?cost?payment.
Submit?purchasing?requisition?to?local?PT?for?purchasing?packing?material?used?for?clinical?study?medication?transportation.
??Support?supply?of?clinical?study?related?equipment,?such?as?thermometers?to?the?study?site?as?per?country?study?team's?request?and?ensure?thermometer?calibration.
??Provide?support?for?importation?of?clinical?study?used?materials?(like?lab?kit,?pad,?booklet,?etc).
??Work?with?local?PT?to?review?and?provide?inputs?to?clinical?supply?related?local?SOPs?before?approval?in?Condor?system.?Deliver?related?training?to?targeted?people?to?ensure?proper?implementation.
??SAP?key?user?from?PDG?CCO?China,?to?liaise?with?local?IT?to?solve?local?SAP?issue?if?required?and?provide?related?training?to?new?SAP?user?if?applicable.
Qualifications:
??University?degree?or?equivalent?or?above,?majored?in?medicine/pharmacy/science?related?is?preferred
??Experience?in?Clinical?Research/Development?or?related?industry?(appreciated).
??GCP/GMP?knowledge?on?clinical?supply?management
