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Job Title:  Clinical Supply Chain Manager 
Department:  Project Services  Location: Souderton,PA,18946 
Job Number:  ACS-PA-PS-SCM-007 
Job Type:  Full Time 
   
   
   
   
   
 Opportunity:
 

The principle function of the Project Services department is the day-to-day management of all Almac Clinical Services customers. The department coordinates all aspects of the delivery of a customer's project as specified in the quotation. In order to achieve this, the department is divided into a customer support group and an operations support group. The operations support group is further divided into two key areas: production and distribution. The Supply Chain Manager works within the customer support group and has overall responsibility for the successful setup and management of the clinical supply chain to ensure the correct drug is in the right place on time, for dispensing to patients enrolled in a clinical trial.

Responsibilities include, but are not limited to:

  • Review the protocol / synopsis and work with Business Development (BD) and the customer to determine the optimal kit design and packaging and distribution strategy, appropriate to the clinical trial.
  • Work with BD and the customer to determine the appropriate level of responsibility for management of the clinical trial being transferred to Almac and ensure this is included in the quotation and Technical Agreement.
  • Assist the Project Leader, when applicable, providing support for the clinical trial (or program) on all elements of drug supply management.
  • Propose a suitable kit design for a clinical study, based on considerations such as drug product characteristics, blinding requirements, dosing regime, visit schedule and availability and cost of bulk drug.
  • Forecast the quantity of kits required both initially and periodically throughout the clinical trial (or program), based on considerations such as randomization scheme, numbers of patients / clinical sites / depots involved, shelf life of drug and projected / actual enrollment rates.
  • Provide information to the Production project team to allow scheduling of production campaigns in line with patient requirements and drug / component availability.
  • Determine the most suitable distribution strategy for the clinical study, based on considerations such as countries involved, randomization scheme, predicted / actual enrollment rates, drug product characteristics and storage capacity at clinical sites / depots.
  • Provide information to the Distribution project team to allow distribution pathways, pack out plans and use of depots to be determined and initiated in line with the clinical study start date.
  • Work with the IVRS/IWRS (or similar automated system) provider to ensure the correct set up of the clinical study in their system, advising on site and depot supply / resupply parameters.
  • Work with the Label Generation group on the design of the labels for the study and if required, assist in drafting the English label text from a GMP compliance and patient perspective (not from a country regulatory perspective).
  • Prioritize, trouble-shoot and problem solve complex clinical supply issues.
 
 
 Required Skills:
 
  •         Bachelor's Degree required
  •         Proven experience & knowledge of the following areas:

           o        Clinical Trial Supply Chain
           o        Clinical Trial Packaging & Distribution
           o        Clinical Trial Legislation
           o        Quality Systems
           o        Almac Clinical Services processes
           o        Business-to-Business Customer Service Experience

  •          Must have experience with randomization Schemes & Kit Lists, IVRS / IWRS
  •          Proficient computer skills - MS Office & MS Project
  •          Communicates effectively with key individuals
  •          Strong negotiating and influencing skills
  •          Strong problem solving skills based on experience and logic supported by confident decision making ability
  •          Ability to identify critical tasks and inter-dependencies
  •          Creative & flexible - can function in the absence of defined processes
  •          Highly motivated, organized and efficient
  •          Accountable, willing to accept responsibility
  •          Capable of processing large amounts of technical information
  •          Willing to travel, as required (maybe up to 30%)
  •          Willing to work overtime, as required
  •          Willing to entertain customers in the evenings, as required
  •          Willing to present at meetings, as required.
 
 
 Benefits:
 
Health Insurance, Dental Insurance, 401(k) 
 

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