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Job #02614

About our client Our client is a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics with an initial focus on cancer, and infectious diseases. 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 Data Manager Eastern Canada Salary Reports to Highly competitive package, commensurate with experience Director of Clinical Operation Responsibilities 1) Contribute to the setup and maintenance of various databases such as the clinical study database, SAE database, and clinical financial databases 2) Collaborate with study teams to support project goals and objectives, which include protocol reviewing, CRF development, monitoring database design, and data management activities of CROs or in-house IT needs 3) Assist in vendor selection and supervise Data Management (DM) and Electronic Data Capture (EDC) vendors 4) Lead regular data transfers and liaise with vendor IT/DM representative 5) Contribute to tracking query generation and resolution process 6) Track and supervise the processes of AE and medication coding, SAE reconciliation, and generation of patient profile review 7) Proficiency in computers and good understanding of computers terminology 8) Develop Data Management (DM) SOPs 9) Lead the setup and maintenance of electronic data collection systems 10) Report and provide performance evaluations (as applicable) 11) Perform any other task requested by Supervisor Requirements 1) Bachelor’s degree/BS or RN preferred and commensurate experience in data management 2) Clinical Data Manager certification a plus 3) Minimum 2 years of experience in the pharmaceutical industry 4) Knowledge of the FDA regulation specifically in 21CRF part 11 compliance documentation 5) Knowledge of clinical trial databases and clinical tracking systems such as Oracle Clinical, SAS, SQL, etc. 6) Line management experience a plus 7) Proficiency in computers and good understanding of computer terminology 8) Knowledge of medical terminology 9) Good organizational skills with strong attention to detail 10) Knowledge of electronic data collection systems and functionalities 11) Superb problem-solving ability 12) Excellent interpersonal skills 13) Fluency in English and French (Quebec only) 14) Effective business communication (oral and written) skills