CLINICAL TRIAL MANAGER NEEDED IN WALTHAM, MA!!

Currently, one of our clients is looking for a dynamic Clinical Trial Manager to help drive and manage the conduct of two Early Phase clinical trials.

Responsibilities:

" Able to work independently and supervise all vendors supporting trials, site audits, contract negotiations
" Assist with study design including protocol writing, and CRF design.
" Function as a hands-on team member internally, and represent the company well externally to medical professionals, customers and investigators.
" Ability to supervise and/or manage all aspects of clinical trials including implementation, clinical site management, and study completion.
" Work with regulatory agencies, and institutional review boards
" Ensure appropriate priorities are maintained for the various projects assigned. 
" Select, interface with, and train investigators, site staff and possibly, the company's clinical staff.
" Able to seek out resources accomplish tasks for various clinical projects to assure achievement of milestones and study objectives.
" Must have a good working knowledge of GCPs, ICH and CFR.
" Design and execute internal guidelines/processes, work instructions, clinical development forms, and department operating procedures.
" Manage budgets, resources and timelines of multiple projects/studies
" Plan and run Investigator meetings, and/ or upper level advisory meetings.
" Work well with other cross functional departments with both internal and external clients

Requirements:
BS degree with (5+ yrs) in Clinical Trial Management.  Medical Device or Drug Delivery background and a plus.  Excellent communication skills and proven track record of successful trial management within early phase studies.