Clinical Supplies Specialist

Job Title: Clinical Supplies Specialist

Location: Buckinghamshire

Duration: 12 month contract

The Client: A global pharmaceutical company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Project Management support

Under direction and supervision of Manager support the following responsibilities for assigned programs:
Interface with customer groups (e.g. Clinical Operations, Supply Operations, Regulatory, etc) to ensure coordination of all activities necessary to deliver and maintain an adequate supply plan.
Employ project management techniques to support supply chains for clinical studies. This includes:
Maintain supply plan, manufacturing plan, inventory plan and distribution plan.
Maintain blinding strategy and ensure implementation
Under supervision provide input for packaging configuration and labeling strategy.
Support and maintain system specifications (IVRS).
Provide support to established outsourcing activities (sourcing, manufacturing, warehousing, distributing).
Support programs, typically those with medium-level complexity, medium priority.

Department Initiatives

Contribute to department by optimizing existing or creating new methods and techniques.
Provide support for short term CSM department initiatives.
Perform other functions as assigned.

Clinical Supply Management

Ensure timely and cost efficient supply availability throughout study execution.
Participate in cross functional, international supply chain-related teams when required (e.g. Forecast meetings, CMC Team Meetings, Clinical Team Meetings, etc).

Regulatory Compliance

Maintains proper control of operations by following SOP's, Manufacturing Procedures, GMP Standards, and other pertinent regulatory requirements.

Full details available on application

The Candidate:

MINIMUM REQUIREMENTS

Education and Experience

Bachelor's degree or equivalent in life science (e.g. pharmacy, chemistry, biochemistry or similar).
Relevant working experience, preferably in the biotechnology, pharmaceutical or medical devices industry or CROs.
Understanding of supply chain management and clinical research management principles.
Understanding of project management techniques.
General understanding of regulatory guidelines impacting clinical supplies (i.e. GxP, ICH guidelines, Clinical Trial Directive)

Essential Skills and Abilities

Sound judgment, analytical, problem-solving and decision-making skills.
Good organizational skills.
Self-motivated.
Ability to handle multiple assignments and priorities simultaneously in a fluid environment with time pressures.
Ability to anticipate and prevent potential problems.
Experienced user of MS Office applications.
Strong verbal and written communication skills.
Ability to operate, with composure and confidence, in a team or matrix environment.

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

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 process.

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