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Job #03082

About our client Our client, based in Arizona, is a leading specialty pharmaceutical company focused on treating skin conditions. They are devoted to helping patients attain a healthy and youthful look and self-image. Our client has numerous leading branded prescription products in various therapeutic categories, like acne, fungal and skin infections. With a stable business in North America and an amazing track record of revenue, operating income growth and impressive gross profit margins, this is an exciting opportunity for someone to join a stable and profitable company. Position Location Clinical Study Manager Scottsdale, Arizona Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the development and management of complex Phase I – IV clinical research studies according to applicable federal regulations and guidance, ICH, GCP as well as company SOPs 2) Rely on experience and judgment to plan and accomplish goals 3) Guide work procedures and standards to improve efficiency and effectiveness of the department 4) Respond to problems effectively while remaining attentive to the protocol requirements, regulations, sponsor goals and investigative site clinical practices 5) Oversee in-house management of complex Phase I – IV clinical research studies 6) Oversee development of clinical start-up plans 7) Supervise selection and qualification of vendors and investigational sites 8) Oversee development of study documents, forms and manuals required for clinical trial management in the manner specified by company's clinical research SOPs related to study documents and in compliance with FDA regulations and ICH guidelines 9) Follow a format suitable for review by FDA Investigator 10) Incorporate protocol knowledge, data management requirements and a firm understanding of the desired study end point 11) Design and manage the tracking of clinical study progress 12) Provide regular verbal and written study status reports to the Clinical Team and upper management 13) Review data (monthly) 14) Organize, plan and coordinate Investigator meeting (quarterly) 15) Attend clinical Project Team meetings (weekly) 16) Maintain awareness of developments in the field of clinical research by reading relevant literature, attending clinical group meetings, etc. 17) Assist in the on-going review/development of SOPs (weekly) 18) Provide expertise regarding clinical-regulatory requirements (daily) 19) Provide monthly protocol development/review 20) Provide weekly training/development of the clinical team 21) Assist with problem solving and decision-making 22) Seek educational opportunities regarding changes in FDA regulations/ICH guidelines (on a quarterly basis) Requirements 1) Bachelor’s degree in the Health Sciences or a related field 2) Minimum 2 years of working experience in a healthcare environment 3) 2 – 5 years of experience in clinical research and/or clinical study programs 4) Dermatology research experience preferred 5) Proficiency in computers (MS Word, Excel, PowerPoint and email systems like MS Outlook) 6) Experience in the IND to NDA application process 7) Knowledge of GCP and pharmaceutical record management 8) Knowledge of study timelines as well as FDA and IRB reporting requirements 9) Understanding of the rationale and genesis of company SOPs to be able to appropriately interpret and apply them to clinical-trial settings 10) Excellent knowledge of federal regulations, GCP, ICH and company SOPs regarding clinical trial site and vendor qualifications 11) In-depth knowledge of the federal regulations, GCP, ICH and company SOPs regarding documentation, regulatory reporting and protection of data integrity 12) Good understanding of the protocol, clinical practices and training requirements 13) Ability to apply federal regulations and guidelines governing clinical trials to management of ongoing studies and development of new pharmaceutical and device clinical trials 14) Ability to effectively manage multiple sites and vendors while maintaining a global view of the clinical development process, ensuring consistency of sites’ understanding and application of the protocol requirements 15) Ability to solve problems efficiently and effectively from a global point of view 16) Ability to anticipate issues that may arise and recommend appropriate actions to be taken