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Job #03447

About our client Our client is a publicly traded pharmaceutical company headquartered in Irvine, CA with over 20 years of success in the development and commercialization of oncology and urology therapeutics. The company has an experienced management team and a robust pipeline of development products. This is a great situation for an Executive that is interested in an opportunity to have a visible impact on a growing organization. Position Location Clinical Trial Manager Irvine, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the Clinical Project Team for one or more clinical protocols 2) Function as an expert resource for clinical trial monitoring activities 3) Propose staffing for new and/or existing projects 4) Plan resources when study expansions and contractions are anticipated 5) Review and approve CRA travel arrangements as well as expense reports (complying with established travel policy) 6) Provide specific study protocol training 7) Review and approve clinical monitoring reports 8) Ensure that CRAs comply with all Clinical Department SOPs, GCP, FDA and ICH regulations governing clinical trials 9) Manage clinical studies in accordance with the company SOPs, GCPs, FDA and ICH regulations 10) Oversee site selection including completion of qualification visits and site initiation 11) Handle study monitoring including on-site visits to ensure protocol adherence 12) Resolve site problems and review data query forms 13) Ensure all required communication and compliance to ensure monitoring is being conducted in accordance with the company’s monitoring standards 14) Complete and approve monitoring reports within prescribed timelines 15) Oversee study termination (resolving data query forms, reviewing record retention, securing investigator report to the Ethics Committee or IRB as required) 16) Participate in drug development activities including writing and updating sections of reports 17) Monitor capacity of staff and assign sites to maintain equity within the group (taking into account CRA capabilities and level) 18) Participate in protocol development and CRF design 19) Serve as an expert adviser to projects (as required) 20) Ensure quality and integrity of clinical trial data 21) Participate in development and writing of protocols as well as final clinical/statistical reports (coordinating with staff in clinical development) 22) Ensure that studies are initiated and completed in a timely manner to meet project timelines 23) Assist in management of various clinical study contractors including selected CRO staff and contract CRAs (domestic and international) 24) Participate in authorizing clinical SOPs, project clinical management plan, site reference manuals, CRF completion guidelines and other clinical documents used as reference materials in clinical studies 25) Ensure that monitoring visits are scheduled at appropriate time intervals and adjusted to manage various patient accrual rates 26) Recommend courses of action to the Director of Clinical Operations regarding management/HR matters for the Clinical Monitoring Team (including salary administration, hiring, firing, performance appraisals, etc.) 27) Ensure that CRAs manage sites for timely, accurate collection of data and appropriate query resolution 28) Keep the Director aware of need for increases in staff and equipment as well as HR problem areas 29) Identify ongoing training/development needs of staff and provide training, guidance/mentoring to CRAs and CRA assistants 30) Apply appropriate principles of constructive criticism to improve site management and encourage excellence 31) Maintain awareness of overall development in the field of clinical research and monitoring based on current literature, professional meetings, etc. 32) Ensure that immediate staff remains current on clinical monitoring developments 33) Perform other duties as assigned Requirements 1) Bachelor’s degree in Biological Science (or related field) 2) Minimum 3 years of experience as a CTM, managing CRAs 3) 5 – 7 years of clinical research experience 4) Phase III clinical trial experience (oncology or urology preferred) 5) Strong interpersonal and organization skills 6) Excellent computer (MS Office) and communication (written and oral) skills 7) Superb leadership skills and ability to work productively as a member of the Clinical Team 8) Quality service attitude and willingness to work additional hours to meet clinical deadlines