Clinical Trials Manager - Remote

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timePosted 13 days ago location United States salarySalary undisclosed
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Job Description

Required Technical SkillsJob Title Clinical Trials Manager - IIILocation Santa Monica, CA, Foster City, CA, Seattle, WA, or Remote.Duration 6 Months DescriptionWe are seeking a highly motivated individual to join us as a Clinical Trials Manager, Clinical Operations. You will manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulationsICH guidelines. The position will report to the Program Manager of Clinical Operations. NOTE This position can be located onsite in Santa Monica, CA, Foster City, CA, Seattle, WA, or Remote. Responsibilities include but are not limited tomiddot Oversees all operational aspects of assigned clinical trial(s).middot Oversees clinical trial conduct including study start-up, enrollment, study conduct and close-out.middot Prepares and reviews study-related and essential clinical study start-up documents (e.g., Clinical protocols, Informed consent forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Provides oversight and guidance if some tasks are delegated to a Clinical Trials Specialist.middot Participates in study strategy development, Line Listing Review, and Clinical Study Report preparation, as appropriate.middot Manages the study project plan, including timelines and budget.middot Provides training and manages CRO vendors such as IVRS, Central lab, Imaging.middot Works with CRO to develop and revise study specific plans and detailed timelines, and ensure that transferred obligations and performance expectations are met.middot Further manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files). Creates and implements corrective action plan when performance expectations are not being met.middot Proactively identifies potential study issuesrisks and recommendsimplements solutions.middot Participates in the selection, training and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function. Prepares metrics and updates for management, as assigned.middot Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings.middot Reviews site study documents (informed consent template and study toolsworksheets).middot Serves as a liaison and resource for investigational sites.middot Participates in the development, review and implementation of departmental SOPs and processes.middot Attends cross-functional meetings as needed to represent Clinical Operations and study-specific issues.middot Provides mentorship and career development to direct reports.middot Other duties as assigned. Basic Qualificationsmiddot BSBA in nursing, science or health related field with 6+ yearsrsquo experience of related oncology clinical trial management experience OR middot MSMA in nursing, science or health related field with 4+ yearsrsquo experience of related oncology clinical trial management experience Preferred Qualificationsmiddot Highly competent knowledge of transplant patient care and apheresis collection a plus.middot Extensive clinical research knowledge and cross-functional understanding of clinical trial methodologymiddot Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies managementmiddot Highly developed leadership skills to successfully lead a clinical study teammiddot Willing to travel at least 25 (possibly more)middot Ability to deal with time demands, incomplete information or unexpected eventsmiddot Must display strong analytical and problem solving skillsmiddot Attention to detail requiredmiddot Outstanding organizational skills with the ability to multi-task and prioritizemiddot Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environmentmiddot Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities