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Job #03023

About our client Our client is a rapidly growing pharmaceutical company headquartered in Northern California that is focused on the development and commercialization of various oncology therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Clinical Operations Manager Emeryville, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the activities and personnel associated with the evaluation, initiation, management and closeout of clinical trials within the Clinical Development Department 2) Work with the Clinical Operations Team in the development and management of a Clinical Trials Management System (CTMS) 3) Identify clinical infrastructure gaps and develop systems/processes for addressing the gaps 4) Work in a matrix environment and collaborate with colleagues in Clinical Data Management, Biostatistics, Regulatory, Safety and Project Management 5) Install and validate 21CFR Part 11 compliant CTMS 6) Manage CTMS vendor relations and the day-to-day use of CTMS 7) Prepare and implement training procedures for CTMS application 8) Monitor field use of CTMS as well as recommend and implement improvements 9) Identify, select and monitor investigational sites for clinical studies 10) Manage team of Clinical Operations personnel including CRAs and clinical assistants 11) Ensure studies are carried out according to study protocol, SOPs and ICH/GCP regulations 12) Track progress of study including patient enrollment and monitor visits 13) Prepare and monitor study metrics against agreed upon targets 14) Investigate queries and monitor discrepancies 15) Manage the site conduct as well as the investigational product accountability and reconciliation process 16) Manage budget and payments for investigative sites and contract organizations 17) Write or contribute to the preparation of clinical protocols, amendments, consent forms, study guides, CRFs and any other clinical research-related document 18) Develop queries for data analysis 19) Negotiate and finalize Investigator budgets 20) Review data listings and summary tables including query generation 21) Oversee performance of CROs and contract CRAs to ensure compliance with study protocol 22) Monitor (jointly) sites with CRAs 23) Train CRAs on protocols and practices consistent with company and GCP standards 24) Assist in identifying and hiring appropriate CROs and study vendors 25) Generate and/or review relevant sections of clinical study reports, IND annual reports and Investigator brochures 26) Collaborate with CRAs and directors to identify Clinical Operations’ process needs 27) Identify/develop processes and procedures for enhancing department efficiency 28) Develop plans for implementing departmental infrastructure enhancements 29) Conduct SOP gap analysis and oversee preparation of new or modified Clinical Operations SOPs Requirements 1) Bachelor’s degree in a scientific discipline or equivalent 2) Minimum 7 – 10 years of clinical research experience 3) 4 – 5 years of clinical trial/project management experience 4) Minimum 3 years of Clinical Operations Management experience 5) Experience in reviewing adequacy of site-proposed informed consents for compliance with relevant regulations 6) Experience in administering site budgets and grants with supervision 7) Oncology experience preferred 8) Knowledge of GCP/ICH guidelines including an understanding of regulatory requirements 9) In-depth knowledge of clinical study management 10) Understanding of FDA regulations and GCP 11) Ability to work independently as well as exercise good judgment in planning and accomplishing goals 12) Superb communication skills (oral and written) 13) Good organizational and planning skills 14) Ability to deal with time demands, incomplete information or unexpected events 15) Ability to work effectively in a team/matrix environment 16) Proficiency in computers 17) Willingness to travel (up to 25%)