As a CTM, you will be leading the Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with international guidelines such as ICH-GCP as well as relevant local regulations.
In addition to leading LST(s), as the CTM you may perform site monitoring as needed to support the flexible capacity model.
• Has the overall responsibility for the study commitments within the country and for
timely delivery of data to required quality.
• Leads Local Study Team consisting of CRAs, CTAs, and Study Start-up Specialists for
assigned study/studies
• Leads and optimizes the performance of the Local Study Team(s) at country level
ensuring compliance with SOPs, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential
studies is performed to the highest quality.
• Coordinates the site selection process by identifying potential sites/investigators,
performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits
to evaluate suitability and quality risks.
• Ensures timely preparation of country financial Study Management Agreement (fSMA)
and maintains accurate study budget in the clinical studies financial system by regular
checks of the system and financial reports
#LI-YY1
• Bachelor’s degree in related discipline, preferably in life sciencqualification (*).
•Min 5 years experience in Clinical research , at least 1 year CTM experience is preferable
• Good knowledge of international guidelines ICH-GCP as well regulations.
• Proven ability to lead and motivate cross-functional teams to deaccording to or ahead of time plan, budget and with required qu
• Excellent project management skills.
• Excellent team building and interpersonal skills.
• Excellent organizational skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent attention to details.
• Excellent knowledge of spoken and written English.
• Good negotiation skills.
• Good ability to learn and to adapt to work with IT systems.
•Oncology experience is must
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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.
Software Powered by iCIMS
www.icims.com