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Clinical Trial Manager

Hello,

My name is Timothy and I represent The Fountain Group. We are a national staffing firm and are currently seeking a Clinical Trial Manager for a prominent client of ours. This position is located in South San Francisco, CA. Details for the positions are as follows:

Job Description:
Provides support and/or leadership to one or more global Study Teams within an early development program(s) (i.e. phase I and II trials). The cCTM is accountable for activities ensuring high quality deliverables are within budget and timelines.
Support cross-functional Study Team within Clinical Operations with minimal oversight from the Sr. CTM and/or CPL
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)
Identify and track timelines, milestones, critical study activities, issues and budget and provide regular updates to the Study Team and CPL as appropriate
Partner with CPL to develop and/or present at project teams and management review bodies
Conduct protocol and site feasibility assessments
Responsibilities and Accountabilities When Leading a Study:
Depending on skill level, study design, and business need, cCTM may lead Study Team, including obtaining agreement on project timelines, budgets, study objectives, and goals.
Ensure relevant functional groups provide input to and participate in developing and finalizing Study Team level documents and meet Study Team level deliverables within timelines
Accountable for Clinical Operations deliverables to achieve study objectives and milestones within timelines and budgets
Provide input to the program budget and is accountable for managing overall study budget where assigned
Delegate and oversee study activities assigned to Clinical Operations Study Team as applicable
Provide drug supply assumptions to clinical planning team
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
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

If you are interested in hearing more about the position please respond to this posting with your resume attached.


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