Clinical Supply Manager in West Lothian / Remote

Location
West Lothian
Salary
Negotiable
Posted
13 Nov 2018
Closes
11 Dec 2018
Ref
KA43936
Contract Type
Contract
CK Group are recruiting for a Clinical Supplies Manager to join a company which is a  global provider of drug delivery technology and development solutions for drugs, biologics and consumer health products for a 6 month contract which may be extended.

The Company:
Our client are the world's number one drug development, delivery and supply partner with over 80 years of experience.  They have helped thousands of innovators by optimising and manufacturing thousands of pharmaceutical, biologic, consumer health and beauty products utilising their superior and innovative drug delivery technologies to improve their value to patients and consumers.

Location:
The position of Clinical Supplies Manager reports to the Bathgate site in West Lothian however candidates working remotely will also be considered.

The Role:
Your main duties will be:
To provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions.

Duties to include:
· Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
· Use simulation tools and supply chain expertise to provide decision in support of the design of optimized, lean supply chains for individual studies or programs
· Create initial study drug projections and supply plan for clinical supply needs throughout life of study including multiple drug campaigns and appropriate drug strategies
· Assist in re-forecasting clinical supplies as a result of strategy changes occurring during the study (enrollment per country, number of sites per country, addition of new countries, etc.) to determine and anticipate the impact on supply forecasts and supply plans
· Assist in creating a supply plan requiring multiple packaging campaigns as a result of limited drug life (short expiry) or limited available study drug
· Provide input to specification design. Recommend threshold levels and optimizes as required to make efficient use of clinical supplies while avoiding stock outs at study sites
· Works with in creation of system specifications (URS) associated with supply algorithms
· Act as Unblinded Study Drug Manager in testing of the system (UAT) and throughout life of the study

Your Background:
The ideal candidate for this role will have:
· Degree qualified or equivalent in a science, supply chain or related discipline
· Relevant industry experience with experience in clinical supply management and demonstrable knowledge of the complete clinical supplies life cycle
· Global logistics experience/understanding related to supply chains, import/export and drug depots, comparator or co-therapy product sourcing and project management
· Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR)
· Working knowledge of global supply labeling requirements
· Extensive experience of using MS Office programs, with a particular aptitude for MS project and Excel

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA43936 in all correspondence.

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