Description
The contract Clinical Trial Manager provides support and leadership to one or more global Study Teams within an early development program(s) (phase I and II trials). The cCTM is accountable for activities ensuring high quality deliverables are within budget and timelines.Primary Accountabilities and Responsibilities:
* Support cross-functional Study Team within Clinical Operations with minimal oversight * Responsible for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budget
* Responsible for vendor selection and management including CRO, IVRS, central lab and imaging vendor
* Provide input to the study budget and is responsible for managing assigned vendor budget(s)
* Under the leadership of the Sr. CTM, takes responsibility for agreed operational aspects (e.g., vendor management, drug supply management)
* Partner with Clinical Program Leader to develop and/or present at project teams and management review bodies
* Conduct protocol and site feasibility assessments
Experience, Skills, Knowledge:
* Experienced in clinical trial management
* Experience in planning, risk mitigation strategies, trial budgets, site selection, clinical supplies management, conduct and monitoring of clinical studies
* Familiar with global trial requirements
* Demonstrated creativity and innovation to support projects and initiatives
* Excellent planning and organizational skills
* Flexible and solution focused
* High level of initiative and ability to work independently
* Strong analytical skills
* Strong customer focus
* Highly effective verbal and written communication skills in English
* 5+ years direct industry study management experience in clinical and drug development
* Bachelors degree or equivalent undergraduate degree (scientific or healthcare discipline preferred)
* Working knowledge of international regulatory and ICH GCP guidelines
To find out more about Real please visit www.realstaffing.com