CTM

The CTM in general, is responsible for the maintenance and further development, and the communication of high-quality standards in the delivery of clinical studies. This includes a key role in ensuring that the training needs in the local SMM (Site Management & Monitoring) team are fulfilled in cooperation with the local SMM leadership team. The CTMprovides compliance and process advice to their local SMM team and identifies opportunities for quality and process improvements on local, regional and global level. In partnership countries this role provides clinical quality management activities and typical accountabilities, to SMM BioPharmaceuticals and to SMM Oncology local teams The CTM is responsible for the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials.

Provides advice to Local Study Teams on the client procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations. • Provides competent advice on local regulations related to clinical trials, keeps abreast of changes in local regulations related to clinical trials and keeps local teams and local processes updated. • Ownership of local procedural framework. • Supports local management in the planning and conduct of local quality control activities as described in the local annual quality plan, including performing accompanied site visits. Performs any required QC visits / QC activities with local staff and maintains the annual quality plan updated. • Provides local management with information regarding status of quality observed in the local SMM

Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*). • At least 5 years of experience in the pharmaceutical industry, preferably in Development Operations/Quality Assurance. • Good knowledge of international guidelines ICH-GCP as well as relevant local regulations. • Good understanding of the drug development process and related GXP activities. • Good understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management, site management, monitoring. • Excellent organisational skills. • Excellent verbal and written communication skills. • Excellent ability to prioritize and handle multiple tasks. • Excellent attention to detail

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.