Primary purpose and function of this position:
The primary responsibility of the Clinical Supply Chain Senior Manager is esure on time supply to all ND clinical trials following study protocols, clinical
study regulation and quality esurance instractions. Clinical Supply Chain Senior Manager is responsible for packaging and labeling of drug and medical
devices for clinical trials and its distrabution to the clinical sites.
Clinical Supply Chain Senior Manager will manage the regional clinical supply functions and will take part in the design, planning and initiation of the
clinical trials in partnership with all other functions. The Clinical Supply Chain Senior Manager is also 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 study protocol, collects and communicates suggestions for a protocol change to responsible author.
· manage regional clinical supply functions
· 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 all study items as required to ensure timely delivery within the specification, quality and standards
· Work in synchronization and collaboration with Planning and logistics functions to initiate procurement, secondary packaging activities and global
shipments guarantee on time supply to clinical trials
· facilitate the process for final drug and medical devices release to clinical trials.
· Initiate label generation and oversee approvals, label regulatory adaptation and translations activities in collaboration with CRO and 3rd party
vendors
· Design IRT %28Interactive response technology%29 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 %28back-up countries, inventories, shelf life, etc.%29
· 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.
· Act as the subject matter expert for clinical trial supply during regulatory inspections
· Develop and monitor vendor Key Performance Indicators %28KPIs%29 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.
%2A And any other task assigned by direct manager
Competencies:
· Expirience in managing global clinical supply chain
· Strong communication and organisational skills
· Strong management and motivation skills
· 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 Requirements:
· College degree or higher, preferentially in pharmacy/ engineering /sciences/supply chain
· At least 7 years of experience in a pharmaceutical industry or supply chain or project mangement and at least 3 years of managing Global clinical
supply chain
· Computer literate
· Fluent in English – Must