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Clinical Trial Operations Manager II - Clinical Supply Chain-Trial Supply Operations
Ref No.: 15-03838
Location: Swiftwater,, Pennsylvania
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 Sanofi Pasteur. 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:
- Delivery of key trial supply documentation (including writing, review and approval as per procedures)

Label specifications (master labels are in English and get translated by translation department) Packaging requirements Packaging instructions when local partner involved Packaging order issuance

- Follow-up of quality control and release activities.
- Follow-up and coordination of shipping clinical logistics activities for timely deliver up to clinical sites.
- Coordination of reconciliation effort and delivery of global reconciliation report.
- Quality control of documentation and archival of trial supply documentation in accordance to trial master file requirements.

Other duties would include:
- Setup, 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).
- Weekly progress report to the CSC Project managers in charge.
- Timely reporting to CSC Project manager of issues that may affect the commitment given to clinical and project teams.
- Provide assistance for conflict resolution

3-6 years of experience
Skills: Thorough 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. Excellent ability to interface with a variety of functional areas within the clinical supply chain. Excellent oral and written communication skills to include presentations in support of training on new procedures. High attention to detail. Excellent negotiation skills. Strong problem solving skills. Excellent ability to multitask and prioritize workload within a dynamic, timeline driven, culturally diverse organization; effective time management skills. Exercises calm, sound constructive judgment during high demanding situations. Ability to organize and lead meetings.

Expected Information solution competencies
- MS Office solutions (word, excel, powerpoint, Excel, Outlook)
- Documentation management systems and Quality management systems
- Collaborative platforms (sharepoint, eRooms)
- Past exposure to SAP would be a plus
- Other solution : project management, purchasing

Education:
Bachelor of Science degree (BS) in Health Science, engineering or related discipline. At least 5 years' experience in pharmaceutical business required, preferably within supply chain, clinical operations or manufacturing environments.
Project management and APICS certifications desired.