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R&D

Clinical Supply Operation Manager

  • Titel Clinical Supply Operation Manager
  • Functie R&D
  • Sub functie Clinical Supplies
  • Locatie Shanghai, China
  • Gepost
  • Referentie 2406173045W
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Beschrijving

General mission

The Supply Operations Manager will manage clinical supplies for clinical trial execution in APAC. He/she will be responsible for project planning and scheduling between internal stakeholders (GCO, CSC, Quality) and external stakeholders (clinical sites & CMOs). The Supply Operations Manager will be the point of contact for clinical sites for CSC & Clinical Operations activities related to CAR-T treatment scheduling & triaging technical issues. This position will be based in Shanghai, China.

Specific missions

•          Close coordination with Clinical Operation team to understand site-based timings for new site initiations, planning, and leading of logistical test runs between Clinical Sites, CPC & MFG.

•          Provides site and study level training related to patient onboarding and all aspects of subject scheduling.

•          For each patient identified for participation in a clinical trial, coordinates & tracks the patient journey, triaging any issues to appropriate stakeholders between apheresis & IP receipt on site.

•          Acts as POC for CPC(s), in providing real-time capacity utilization per patient enrollment across the compound and works to resolve any site-level issues that might impact CPC. Escalates any needs for increase to capacity to CSI – CAR-T.

•         Participates in GCP and GMP health authority inspections. Have previous experience managing work with Contract Manufacturing Organizations to perform capability assessments and provide technical expertise to influence and bridge gap analysis to meet Clinical Trial requirements.

Kwalificaties

Profile needed for this function

Knowledge

•          Requires clinical operational knowledge, project planning, and good communication skills. Experience with clinical trial operations, project management, pharma/bio research and development is preferred.

•          A demonstrated ability and experience to work in a highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines) is required.

•          With some guidance, responsible for any tech support/use resolution at those internal or external stakeholders.

•          Supports proactively in the continuous improvement of the overall supply chain processes.

•          Ability to work in a multi-cultural environment (across geographic regions) is essential.

Degree

•          A Master’s Degree or equivalent desired, preferably in medical, biopharmaceutical related majors with at least 5 years of working experience.

Languages

•          English (Fluent in spoken and written)

•         Japanese/Korean desired

Specific know-how of systems

•            General knowledge of GxP principles

•            Excellent written and verbal communication skills, able to communicate clearly, making the complex clear and compelling to all levels of the organization in both written & oral forms are required.

•            Ability to effectively apply project management tools to lead projects and programs is required.

•            Good at MS Office applications and willing to learn and support new clinical systems development.

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