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Job #02967

About our client Our client provides one of the most comprehensive services, which cover early-stage product planning through to post-approval development. Position Location Senior Manager, Clinical Research Associate California Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate with CRA II Manager and project managers to ensure studies are adequately staffed 2) Work closely with the CRA II Manager, Sr. CRA IIs, and CRA II Training Specialist 3) Ensure CRA IIs receive adequate training for specific job assignments 4) Develop and implement departmental strategies based on current staffing and project needs 5) Ensure adherence to company policies and sponsor’s SOPs 6) Work with CRA II Manager and staff to plan and organize site monitoring 7) Ensure team has consistency with maintaining monitoring folders 8) Obtain feedback from CRA II Manager and project managers to ensure timely submissions of monitoring reports and follow-up letters 9) Work closely with CRA II Manager and Senior CRAs to resolve monitoring issues 10) Report and discuss difficult issues with the Director of Project Management for possible resolutions 11) Work with CRA II Manager to monitor workloads and make adjustments as needed 12) Attend applicable study team teleconferences/meetings and Investigator meetings and provide support, as needed 13) Conduct CRA II staff interviews 14) Hire, train and manage staff in India/off-shore Requirements 1) Bachelor’s degree in Life Sciences 2) Experience in conducting clinical trials 3) Familiarity with managing staff in foreign offices, particularly India 4) Knowledge of FDA regulations/ICH guidelines