TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
The Clinical Logistics Coordinator is responsible for investigational product cell journey logistics chain of custody and chain of identity.
In so doing this role collaborates with several cross functional stakeholders including clinical trial personnel Clinical Operations Data Management Clinical Development Medical Affairs Regulatory Affairs Technical Operations Manufacturing MSAT and Quality.
This role is a part of the study management team and reports to the Clinical Operations Logistics Manager.
Responsibilities (include but are not limited to):
Arranges product cell journey logistics: all transport legs customs courier and broker interactions
Communicates study enrolment requirements pertaining to the cell journey
Contributing member of Clinical Trial study teams
Drives the cell journey for assigned primary and backup studies
Engages Contract Research Organizations to facilitate the cell journey
Interacts with investigational site medical personnel
Maintains product chain of identity and chain of custody
Participates in 24/7 oncall response program
Provides training at study trial meetings as needed
Tracks and prepares cell journey information utilizing databases spreadsheets and other tools
Utilizes vendor/supplier systems to place relevant orders
Works crossfunctionally with Technical Operations Manufacturing Quality and other depts to facilitate the clinical product cell journey
Arranges meetings agendas and minutes
Travel as needed
Other duties as assigned
Basic Qualifications:
4 years of relevant clinical or logistics experience
2 years of relevant clinical or logistics experience with a BS/BA
0 years of relevant clinical or logistics experience with a MS/MA
Preferred Qualifications:
Detail oriented
Able to work independently and as part of a team
Excellent verbal and written communication
Experience with Agile change control management a plus
Experience with courier services
Experience with CRM systems: Salesforce Oracle SAP a plus
Experience with ERP systems: Oracle SAP a plus
Familiar with domestic and international logistics/transport of biologic material (IATA ICAO ADR DOT WHO).
Knowledge of biological tissue transportation and logistics
Required Years of Experience:
25 years
Top 3 Required Skill Sets:
Logistics background clinical trial experience ability to be on call when needed
Top 3 Nice to Have Skill Sets:
Comparator drug sourcing demand planning IT experience
Unique Selling Point of this role:
Ability to work with our clinical trial sites and manage patients cell journey for treatment.
Required Degree or Certification
College degree preferred
Any Disqualifiers
None at this time
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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