Clinical Supply Chain Manager

 
 Reports to: Director of Supply Chain
 
Requirements:
 *College degree or higher, preferentially in pharmacy/ engineering /sciences/supply chain  
*At least 5 years of experience in a pharmaceutical industry
*Experience with supply chain or project  mangement   
*Global trial supply chain or pharmaceutical development experience is a must  
*Fluent in English   Travel (up to 20%) may be required, including international travel
 Note: Any equivalent combination of education, training and/or experience that fulfills the requirements of the position may be considered.
 
 Primary purpose and function of this position:
 Will act as the interface between the Supply Chain, Clinical Operations and Manufacturing CMO’s to ensure timely availability of finished drug products and matching placebos for use in clinical studies. The Clinical Supply Chain Manager will take part in the design, planning and initiation of the clinical supply chain in partnership with all other functions.
 
Will be responsible to provide professional expertise and leadership through leading global departmental tasks and taking initiatives in improving processes.
 
 General duties and responsibilities:
   Participates in the review of the protocol, collects and communicates suggestions for a protocol change to responsible author.  Manages and maintains collaboration with clinical study team in order to define study timelines, kit design and supply planning.  Oversee packaging, labeling, storage and distribution activities for clinical trials  Oversee stock levels and deliver forecasts and specifications of IP, devices, ancillaries, sourcing of comparators as required to ensure timely delivery within the specification, quality and standards   Plan the secondary packaging and facilitate the process for final drug release.  Initiate label generation and oversee approvals, label regulatory adaptation and translations activities in collaboration with CRO and 3rd party vendors  Design IRT (Interactive response technology) system, set-up and oversees maintenance. In collaboration with Clinical Operations and CRO.  Proactive and continuous risk management of the end to end clinical supply chain (back-up countries, inventories, shelf life, etc.)  Develop in-depth knowledge in relevant indications and Clinical Supply Chain aspects  Initiate efforts for improving current processes for better efficiency and faster turn-around.   Assist with leadership activities and projects as needed  Act as the subject matter expert for clinical trial supply during regulatory inspections  Develop and monitor vendor Key Performance Indicators (KPIs) to track clinical supply chain performance  Monitor regularly drug expiry, and the appropriate inventory re-supply   Responsible for Accountability, Returns and Destruction of supplies  Ensures compliance of the clinical supply activities with the ICH GCP, GMP, GDP guidelines and SOPs.     *      And any other task assigned by direct manager
    
 Competencies:
   Strong communication and organisational skills  Strong management and motivation skills  Expirience in managing clinical supply chain   Ability to flag issues in a tiemly manner and perform issue escalation  Flexible and able to work in a global changing enviroment, multi tasking and deadllines  Teamplayer who can also operate independently  Solution-oriented and problem solving attitude  Service oriented   Education and Knowledge