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Job #02617

About our client A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare and animal healthcare products with a strong pipeline Position Location Assistant Director Northeast, USA Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Prepare and execute one or more clinical investigations (pre-study, initiation, interim and close-out visits) 2) Monitor (completion of monitoring confirmation visit letters, trip reports, follow-up letters and study site payments) 3) Co-monitor and audit the work of others as needed 4) Participate in investigator site selection 5) Coordinate vendor/CRO services 6) Initiate, review and negotiate site budget/contracts 7) Participate in sponsor and investigator meetings 8) Review, revise and develop SOPs 9) Schedule and perform the monitoring of one or more clinical investigational sites 10) Design/prepare Case Report Forms (CRFs) 11) Generate study-specific monitoring plans and informed consent templates 12) Prepare clinical study supplies to be shipped to the investigational sites 13) Project the usage of clinical supplies 14) Register patients for clinical investigations 15) Interact daily with appropriate individuals, departments or contractors to support and maintain the clinical investigations 16) Assist in updating investigator’s brochure and final study reports for assigned protocols 17) Collect, process, review and make corrections to Case Report Forms (CRFs) 18) Document and maintain all site contacts on appropriate forms 19) Review tables, listings and study reports for assigned protocols 20) Monitor assigned protocols and/or projects 21) Participate in Clinical Team meetings, lead discussions on assigned protocols 22) Ensure following of company’s SOPs, GCPs and ICH guidelines 23) Review literature 24) Prepare timely reports on the status of clinical investigations 25) Assist in the preparation and completion of IND, BLA, NDA documents, as well as product annual reports and final safety reports 26) Train and supervise CRO personnel to ensure consistency and compliance in monitoring clinical investigations Requirements 1) Bachelor’s degree + 7 years of related experience/master’s degree + 5 years of related experience/doctorate + 2 years of related experience 2) Experience in oncology research and/or clinical trials preferred 3) Direct experience in clinical trials and at least 1 year within industry and/or clinical research organizations 4) Protocol design experience 5) Scientific/medical knowledge to author and firmly understand a protocol and other study documents prepared by Medical Research 6) Working knowledge of statistics, data analysis and data interpretation 7) AE/SAE expertise 8) Limited exposure to drug development process with broad level of exposure in one or two areas 9) Demonstrated ability to integrate and summarize medical/scientific concepts in protocols and other documents 10) Strong understanding of basic physiological and pharmacological principles 11) Excellent communication (written and oral), organizational and cross-functional collaboration skills