As a Senior CTM you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
In partnership with Clinical Study Management, provide guidance and daily oversight for the successful in-house management of all aspects of international clinical trials, delivering high quality study data, on time and on budget.
Develop and execute operational plans for the successful in-house implementation and management of oncology clinical trials.
Collaborate with cross-functional teams, including data management, clinical scientists, regulatory and investigators, to ensure operational excellence and rapid delivery of high quality data. Ability to examine functional issues from a broader organizational perspective.
Manage all aspects of trial start-up activities, collaborating with other Clinical Operations functions (Site Engagment & Monitoring Excellence, and Supplier Relationship Management & Performance), to deliver efficient and effective site selection, feasibility assessments, and preparation of study-related documentation.
Collaborate with other Clinical Operations functions (Site Engagment & Monitoring Excellence) to efficiently and effectively deliver study site initiation, training, and monitoring activities to ensure adherence to study protocols, regulatory requirements, and ICH-GCP guidelines.
Collaborate with other Clinical Operations functions (Site Engagment & Monitoring Excellence) to develop and maintain strong relationships with investigators, study coordinators, and study site personnel to facilitate patient recruitment and retention.
Monitor and evaluate study progress, identifying risks, issues, and deviations, and implement appropriate corrective actions to maintain study integrity and timelines.
Ensure compliance with regulatory requirements, including ICH-GCP, FDA guidelines, and other applicable regulations throughout the trial lifecycle.
As required, collaborate with external vendors, including CROs, central laboratories, and imaging providers, to ensure their efficient and effective deliverables to the trial.
Contribute to the development and review of study-related documents, such as protocols, informed consent forms, case report forms (CRFs), and standard operating procedures (SOPs).
Prepare study materials and establish procedures to ensure adherence to study protocols and administrative requirements.
Lead the creation and maintenance of all study files, including the study master file, and oversight of site files.
Lead periodic review of the Sponsor Trial Master File.
You are:
Bachelor's or advanced degree in a relevant scientific discipline
Minimum of 5 years of experience in Clinical Operations; Oncology trial management experience preferred
In-depth knowledge of clinical trial regulations, guidelines, and best Practices, including ICH-GCP and FDA requirements, specific to oncology research
Demonstrated experience in managing and executing clinical trials from start-up to closeout
Strong project management skills, with the ability to effectively prioritize tasks, allocate resources, and manage study timelines and budgets
Excellent interpersonal and communication skills, with the ability to collaborate effectively with stakeholders at all levels, and create a clear sense of direction as necessary
Detail oriented with strong analytical and problem-solving abilities, capable of identifying and mitigating study risks and deviations
Proficiency in using Veeva clinical trial management systems (CTMS) preferred
Understanding of oncology therapeutic areas, including familiarity with oncology treatment modalities, disease progression, and related medical terminology.
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.
Our benefits examples include:
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, colour, 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.
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