Clinical Supply Chain Manager ** open to several EMEA …, Bloemfontein

Summary The position provides customer-focused leadership of operational and financial aspects of clinical trial supplies management during the complete project life cycle. Duties include liaising with customers, vendors, and investigative sites to manage Clinical Trial Supplies deliverables. Assignments may range in size and complexity from single service studies to full-scope, multiple-protocol projects and global projects across various phases and functional areas.

Job Responsibilities

Manages clinical trial supplies for assigned studies and ensures compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements.

Accountable for the operational delivery and financial performance of services assigned to the Clinical Supplies team.

Liaises with the Supply Chain Logistics Coordinator for IoR/EoR services as required.

Leads the identification of and contracting with approved Clinical Trial Supplies-related vendors, as necessary.

Provides vendor management, inclusive of ensuring key Clinical Trial Supplies deliverables are met and financial parameters of contracts are upheld.

Defines supplies requirements in collaboration with client packaging and distribution vendors and the Project Lead (PL).

Provides oversight for the creation, implementation, and maintenance of drug and supply distribution plans.

Accountable for maintenance of project information on a variety of databases and systems.

Oversees the inventory, supply, and re-supply plans for subject kits and/or study medication required for the duration of a study and provides relevant reports for customers and management.

Provides oversight for development and implementation of project plans in accordance with Controlled Documents and ensures proper archival of records in Trial Master Files to ensure inspection readiness.

Develops contingency planning and risk mitigation strategies to ensure successful provision of all required clinical trial supplies.

Participates in bid defense meetings to demonstrate overall capabilities of the Clinical Trial Supplies Management team and specific strategies for management of clinical trial supplies logistics for new business opportunities.

Develops strong relationships with current and potential customers to ensure satisfaction and identify new business opportunities.

Qualifications

Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or a related field.

Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company in project management or clinical trial supplies management.

Strong knowledge of Good Clinical Practice, ICH guidelines, Good Manufacturing Practices and other applicable regulatory requirements.

Strong organizational skills.

Strong ability to manage time and work independently.

Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.

Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.

High level of competency in English language.

Proficiency with MS Office Applications.

Ability to travel as necessary (up to 25%).

Disclaimer Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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