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97424 - Clinical Trial Manager II, Clinical Supplies


A Clinical Trial Operations Manager II (Clinical Supply Chain/Trial Supply Operations) is needed for a 7-months contact position at major pharma company in Northeast.
The role of the Clinical Supply Chain team is to interact at Project Team and Clinical team level to streamline product flow management throughout the product value chain: sourcing, packaging, distribution and reverse logistics.
The Clinical Supply Chain team provides tactical and operational oversight and support on the totality of the company. Those trials spread worldwide and can be sponsored by Clinical R&D, US medical affairs, global medical affairs and in some instances external sponsors. Therefore CSC team is working from phase1 trials to phase4 trials with both new vaccines and registered vaccines. The clinical supply chain objective is to sustain 90% timeliness in the delivery of clinical supply material up to clinical sites. On a yearly basis, an average 50 trials are managed by the CSC team worldwide at different stage (preparation, start-up, close-out).
Expected deliverables for clinical supply chain trial operations:
oDelivery of key trial supply documentation (including writing, review and approval as per procedures)
oLabel specifications (master labels are in English and get translated by translation department) Packaging requirements Packaging instructions when local partner involved Packaging order issuance
oFollow-up of quality control and release activities.
oFollow-up and coordination of shipping clinical logistics activities for timely deliver up to clinical sites.
oCoordination of reconciliation effort and delivery of global reconciliation report.
oQuality control of documentation and archival of trial supply documentation in accordance to trial master file requirements.
Other duties would include:
oSetup, preparation and facilitation of working sessions with the key participants (trial managers, clinical logistics coordinator, clinical statistician, packaging unit coordinator, quality representatives, shipping unit representative).
oWeekly progress report to the CSC Project managers in charge.
oTimely reporting to CSC Project manager of issues that may affect the commitment given to clinical and project teams.
oProvide assistance for conflict resolution

Minimum Requirements:
Education and
Experience:
oBachelor of Science degree (BS) in Health Science, engineering or related discipline
oAt least 5 years' experience in pharmaceutical business required, preferably within supply chain, clinical operations or manufacturing environments.
oProject management and APICS certifications desired
Skills:
oThorough understanding of GXP regulations with respect to vaccine label/packaging, distribution, returns, and reconciliation as well as experience with supply chain procedures and clinical trial operations is required
oExcellent ability to interface with a variety of functional areas within the clinical supply chain
oExcellent oral and written communication skills to include presentations in support of training on new procedures
oHigh attention to detail. Excellent negotiation skills
oStrong problem solving skills
oExcellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills
oExercises calm, sound constructive judgment during high demanding situations
oAbility to organize and lead meetings
Expected Information solution competencies:
oMS Office solutions (Word, Excel, PowerPoint, Excel, Outlook)
oDocumentation management systems and Quality management systems
oCollaborative platforms (Sharepoint, eRooms)
oPast exposure to SAP would be a plus
oOther solution : project management, purchasing

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