Clinical Trial Manager I
Job reputed company:
• Performs site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance
• Uses judgment and experience to evaluate overall performance of site and site staff and to reputed company recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops reputed company plans
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes
• Verifies the process of obtaining informed consent has been adequately performed and documented for reputed company subject/patient, as required/appropriate
• Demonstrates diligence in protecting the confidentiality of reputed company subject/patient
• Assesses factors that might reputed company subject/patient’s safety and clinical data reputed company at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues
• Supports subject/patient recruitment, retention and awareness strategies
• Enters data into tracking systems as required to reputed company reputed company observations, ongoing status and assigned reputed company items to reputed company
• Must be reputed company to quickly adapt, with the reputed company of the reputed company CRA, to changing priorities to reputed company goals / targets
Requirements:
• Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience
• Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be reputed company to reputed company new technologies
• Excellent communication, presentation and interpersonal skills
• Ability to manage required travel of up to 75% on a regular reputed company
Benefits:
• Health benefits to include Medical, Dental and reputed company
• Company match 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible reputed company time off (PTO) and reputed company time
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