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Job #02880

About our client Our client is a dynamic and growing, independent contract drug development and consulting company. Employees at this company are experienced and highly qualified team players, essential to its success. Position Location Manager Clinical Affairs/Project Manager West Coast Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist with the creation and review of protocols, informed consents, CRFs, clinical study materials, monitoring tools and clinical study reports 2) Provide inputs for defining new or revised process development, problem-solving and training (as needed) 3) Maintain frequent contact with and work effectively with investigators, coordinators and other site staff 4) Develop/manage clinical study budgets 5) Prepare and track required documentation from clinical sites 6) Conduct initiation, interim monitoring, and closeout visits and perform drug accountability (as needed) 7) Review and resolve discrepancies in clinical data with clinical sites 8) Maintain regular internal contact with relevant departments such as Data Management, RA, QA, Pre-clinical, Drug Safety and others (as necessary) 9) Provide guidance and direction to contract CRAs in the field 10) Ensure regulatory compliance of investigational sites with company SOPs, FDA and ICH guidelines Requirements 1) Degree, preferably in a scientific discipline, or health-related field 2) 5+ years of clinical monitoring experience 3) Experience in working with dermatology products preferred 4) Experience in Phases I – III of drug development 5) In-depth knowledge of GCP, ICH guidelines, and FDA regulations 6) Ability to work independently on routine CRA work 7) Ability to work with general instructions on new assignments 8) Ability to resolve routine issues independently 9) Excellent problem-solving skills in managing clinical sites 10) Ability to be tactful and diplomatic in dealing with study coordinators and physicians 11) Willingness to travel (within US) – up to 10%