To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02737

About our client Our client is a world leading healthcare company that has developed a reputation for successfully bringing impacting products to market. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Operations Manager Manitoba Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide leadership and direction to the Clinical Operations Team overseeing clinical study execution 2) Oversee and ensure efficient and effective execution of all Phase I – IV clinical plans 3) Supervise financial and resource allocation for clinical development projects 4) Ensure active participation in the development, negotiation, and implementation of budgets 5) Develop, prioritize, and meet measurable short- and long-term objectives for clinical research programs 6) Ensure that trials are designed and conducted according to cGCP and all applicable regulations 7) Draft Request for Proposals (RFPs) for outsourced studies 8) Ensure that the clinical development projects meet predetermined budgets and timelines 9) Select CRO/Central laboratory/investigator sites 10) Negotiate budgets with CRO/Central laboratory/investigator sites 11) Manage and direct service providers including CRO(s) for conducting global clinical drug development programs that support regulatory approval and subsequent commercialization 12) Provide oversight of site management activities, including monitoring and ongoing communication with investigative sites 13) Track progress of clinical development programs and address problems (as necessary) 14) Develop Study Procedures Manuals (SPMs) 15) Organize and participate in Investigator meetings 16) Ensure appropriate, comprehensive, and professional communications both internally and externally 17) Provide inputs for the design and implementation of clinical protocols, quality assurance, data collection systems, and final reports 18) Build, coach, and mentor the Clinical Operations Team 19) Review and maintain clinical operation’s SOPs (as required) 20) Provide leadership to the management for global clinical development programs Requirements 1) MD and Ph. D. or Master’s/Bachelor’s degree in Life Sciences or equivalent relevant experience in a scientific or nursing discipline 2) 5 years of experience in the pharmaceutical industry 3) Hands-on experience in managing high quality, successful clinical trials and clinical trial project teams 4) Experience in managing projects and people 5) Knowledge and understanding of Health Canada, FDA and ICH regulatory requirements along with procedures applicable to clinical research 6) Ability to set and communicate goals, drive efforts, overcome obstacles, and achieve results within budget and timeline specifications 7) Ability to coordinate a variety of tasks in a highly diverse and fast-paced, team environment 8) Ability to provide leadership and guidance to staff 9) Excellent organizational, analytical, leadership, problem-solving, and interpersonal skills 10) Excellent computer skills 11) Superb communication (written and verbal) skills