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Clinical Trial Supply Manager / CTS Manager / CTS Project Manager
Clinical Trial Supply is a vital component in the worldwide Clinical Trial sector. Although some pharmaceutical companies undertake their own clinical trial management, many outsource this vital function to specialist Clinical Trial Supply (“CTS”) companies. CTS organisations act as an essential link between the pharmaceutical or Biotech companies that have developed the drugs to be trialled and the Clinical Research Organisations (CROs) that run the clinical trials. Clinical trials can range from Phase I and Phase II trials with relatively small numbers of participants in a few countries through to multi-national Phase III trials in 30+ countries with thousands of participants.
Clinical Trials Supply staff will have a full understanding of Project Management and Supply Chain Management relative to Clinical Supplies. This will include a knowledge of all trial phases and how protocols translate into the entire supply chain plan. Areas of responsibility will include sourcing, packaging, labelling, inventory control, cold chain storage and worldwide distribution of the drugs being trialled. Strict compliance with national and international regulation and manufacturing practices (cGMP) standards is essential at all stages of the supply chain. It is vital that drugs arrive at the trials at exactly the right time and that they have been expertly packaged to protect the sensitive biological clinical trial materials from environmental conditions in transit such as temperature, humidity, light and X-ray scanning.
In a 3rd party CTS business, there is an additional emphasis on offering the best possible customer service, whether your clients are Big Pharma or smaller Pharmaceutical businesses. Acting as the client’s point of contact and project owner, these roles encompass the management of critical and highly regulated projects that incorporate design coordination, materials specification, operations and tracking technology. The job holder will devise and agree project specifications, then manage and coordinate the project execution through to successful delivery. This involves substantial communication and coordination between the client, the operational departments and external third party service providers.
This is a fast-paced and time critical environment requiring a flair for, and enjoyment of communication with people at all levels. Full, and structured training will generally be provided in the company’s services and processes following an analysis of individuals training needs.
Skills and Experience Required for a Career in Clinical Trial Supply Management
- Bachelor’s Degree in a science, operations management or other relevant subject
- Excellent interpersonal skills
- Ability to multi-task
- Understanding of clinical trial procedures
- The ability to work in a very fast-paced setting
Careers in Clinical Trial Supplies are varied and interesting. Graduate entry level salaries start at around £25,000 and can increase to around £35,000 for an Associate Clinical Trial Supply Manager with 3-5 years’ experience and up to £50,000 for a Clinical Supply Chain Managers. Some people might take more of a project-focused direction, whereas others might begin to specialise more in particular areas of cold chain logistics, cold chain packaging, cold storage and freight forwarding.