Senior Clinical Supply Study Lead

TheSenior Clinical Supply Study Lead (sCSSL) design and executeoptimizedsupply chainsfor complex global clinical studies across all phases within drug development.

TheSCSSLholdstheoverallresponsibilityfor delivery of IPto a specific studyand co-ordinate associated tasks and activities across all relevant functionssupportingthe supply.Senior CSSL is expected tohave a good understanding of planningbest practiceandtodemonstrateproficiencyin supplyplanning systems.ThesCSSLhave multiple contacts across internal and external groups including leadership of workinggroups.Beyond managing supply to studiesthesCSSLalso provide mentoring and support to already experienced colleagues and drive improvements and processes in the Clinical Study Supply area.

Key responsibilities for role:

• Execute study deliveryfollowing planning processes to optimiseservicewasteand cost impact.

• Mentorsupportand coachalready experiencedCSSLs managing complexanddemandingclinical studiesto setup and execute supply in an optimized way.

• Lead or be a key contributor inbusiness developmentprojectsor initiatives. Especially inthe areas ofsupply chainexcellencedigital capabilityand drive the implementation of thisin the CSSL community

• The Senior Clinical Supply Study Leadcan be abusiness process owner foradefined supply chain process.

• Drive improvement initiatives

• Identify manage and mitigate risksin studiesand the business area

• Actand promoteaccording toLean LeadershipHabits and Behaviours

While managingsupply to astudy theresponsibilitiesare:

Study Designinfluence:

• Input to Study Design Concept Clinical Study ProtocolHandlingInstructions Pharmacy Manual or other relevant

• Works in collaboration with the Design specialist andIRTspecialist teams to agreeoptimumSC design usingtheN-SideSuite(formerCT-Fast)where applicable tooptimizeIRTsettings.

• Input to randomizationstrategy

Stakeholdermanagement:

• LeadtheStudy Drug Working Group to enable continuous dialogue with the clinical team onthestudy design requirements and their changes affecting supply chain of the study.

• Contribution to the Supply Chain Team Meetings ensuring effective collaboration with Dev QA Analytical CMC SCPL& Clinical partners (and other ifrelevant)

• Lead/contribute to Kick Off Meetings for relevant suppliers(iePLD clinical CRO IRT)andmaintaincollaboration throughout the studylifecycle

• Escalation of risks / issues / concerns relating to systems andactivitiesthroughappropriatechannels

• Support of specified activities in outsourced studies and partnership with CSOS colleagues.

• Support knowledge sharing andcreatinggreat placeto work environmentamong peersacrosswholeGlobal Clinical Supply Chain

Demand and Supply - planning andmanagement:

• Development/input to key documents reflecting supply chain design& requirements: SSSD (or equivalent) SDPAPSF

• Refined initial and continuous study demand forecastingin order tocreate a Supply Planforsecondarypackingtogetherwithidentificationofrisksrelatedto supply

• Efficientexecution ofchangemanagement(ielabel changes or expiry switches)

• Inventorymanagement leading to waste reduction

Costmanagement:

• AssessmentofprojectedcostsrelatedtopackaginglabellinganddistributionInline with AQIRE process

• Control of ongoing study spend viaPOand invoiceapproval

• Flagging risks related to budget constraints viaSCT

Compliance:

• Management of Quality Events (ieDeviations CAPAs Complaints ChangeControl)

• Contribution to GMP & GCPaudits

• ProvideregularupdateduringTIERmeetings according toSQSCP(SHE qualitysupplycostpeople)priorities

• Ensuring eTMF compliance

• OODreporting

Systemutilization:

• IRT

• Smart Suppliesplatform

• The N-Side Suite

Packing/labelling/distributionactivities:

• Definition and implementation of PLDstrategy

• Kit/Packdesign

• Implementation of TCM and management of thestrategy

• Master Label development (ifrelevant)

• Destructionmanagement

• Expiry datemanagement

• Extension of shelflife

• Rework &recalls

Tasks related to the above areas can be supported whereappropriate by relevant Global Clinical Supply Chain supporting functions (CSC or CSSL) however thesCSSLretains overallresponsibilityfor deliveryof studydrug.

• Working knowledge of the Clinical Trial Directive and global regulatory environmentimpactingthe provision of investigational products.

• Knowledge of Clinical Developmentprocesses

• relevant to investigational products. Lean experience/qualifications

• >2 years CSSL experience