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Job #02418

About our client Our client is a Fortune 500 company and a global leader in its sphere. The company has a strong pipeline of products, which includes pharmaceuticals and healthcare (both consumer and animal). Position Location Assistant Director, Clinical Trial Management Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and direct Trial Execution Team(s) 2) Provide input into the performance reviews of the individuals on their teams 3) Create, manage and report on the Trial Execution Plan through startup, ongoing study execution and site closeout 4) Manage all study communications including internal (study team communications) and external site communications 5) Oversee site selection process 6) Manage, coordinate and facilitate key trial activities 7) Oversee site initiation process 8) Manage relationships and communications with central labs, vendors and CROs 9) Coordinate development, review and timely completion of the Analysis and Database Design (ADD) components with Clinical Development and Medical Research personnel 10) Drive the site budget and contracting decisions, working with the Clinical Contracting Group (CCOG) and Legal 11) Track and report on patient enrollment, site monitoring and site close-out activities 12) Supervise day-to-day activities of Trial Support Specialist(s) assigned to support trial(s) and provide guidance and mentoring Requirements 1) BS/BA plus 8 years of experience, MBA/MS/MA plus 7 years of experience, or Ph. D and Pharm. D + 4 years of clinical research or relevant experience 2) Knowledge of FDA and ICH regulations regarding clinical research and Good Clinical Practice (GCP) 3) Experience in running global, complex studies (large number of patients, sites, scientifically complex, long duration, significant CRO management responsibilities) strongly preferred