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Job #02584

About our client Our client is dedicated to improving and preserving human life by developing innovative pharmaceutical products. The company’s premier product has been developed for delaying/preventing renal flares. Treatment for various other autoimmune and inflammatory conditions have also been developed by the company. Position Location Clinical Project Leader California Salary Highly competitive package, commensurate with experience Responsibilities 1) Liaise with the Project Team (internal and external) 2) Keep the Associate Director updated on project status that include, but are not limited to study start up activities, patient screening, enrollment, screen fails and patient discontinuations, outstanding/late reports from CRAs 3) Coordinate initiation visit with document approval and drug shipment 4) Work to identify and resolve immediate and potential project related issues 5) Provide study specific information and maintain professional working relationship with study staff 6) Participate in the design and development of clinical protocols, development of new case report forms (CRFs) and study related documents for clinical trials, as requested 7) Ensure that required documentation is maintained from clinical sites regarding trial initiation to the conclusion of the study 8) Practice and ensure adherence to the protocol, GCPs, ICH guidelines and company SOPs 9) Develop and implement project specific quality tools 10) Review and track study initiation, monitoring and termination reports from CROs/CRAs to ensure they meet standards and expectations 11) Work with Associate Director ensuring consistency and follow through with all reports 12) Communicate with central laboratory, central Institutional Review Board/Ethics Committee (IRB/EC) and/or drug manufacturer and supply vendors 13) Manage the invoicing associated with specific groups 14) Discuss and plan with the Associate Director-investigator recruitment and selection strategies 15) Ensure implementation of the strategies by Project Team 16) Oversee the regulatory documentation collection process that includes tracking documents 17) Work with regulatory agencies to facilitate approval and providing feedback to CRAs regarding deficiencies in documents to ensure timely submission by CRAs 18) Coordinate regulatory document approval with drug shipment 19) Communicate with investigators and study coordinators via email and telephone 20) Coordinate central file audits Requirements 1) Bachelor's degree in a scientific discipline or equivalent 2) 5 years of experience that includes a combination of monitoring and in-house CRA work with increasing responsibilities in study management in an affiliated therapeutic area 3) 2 years of experience in project management leading of a clinical trial in the pharmaceutical industry 4) Experience in Lupus, inflammatory, arthritis and immunology preferred 5) Experience in multicenter and multinational trial preferred 6) Strong knowledge of FDA regulations, ICH guidelines and GCPs 7) Knowledge of the workflow process as well as roles and responsibilities of multiple functional areas 8) Have a professional demeanor and a customer service demeanor 9) Demonstrated problem-solving skills, a strong sense of urgency 10) Keen attention to detail, the ability to plan and organize 11) Ability to manage multiple priorities related to the ongoing projects 12) Excellent communication (written and oral), interpersonal and teamwork skills 13) Willingness to travel