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Clinical Study Manager II

Overall Purpose This position is responsible for providing project management and leadership to plan, prepare and execute multiple clinical projects. Internally interfaces with data management, clinical research associates, Quality, Regulatory, and functional management. Acts as liaison with external customers including site investigators, clinical site staff, and medical and scientific personnel. Accountable for timeline development, communication, and accountability of study outcomes and milestones to internal and external customers. Skills Requirements Solid understanding of the clinical study process, preferably of medical devices. Proficient working knowledge of the regulations (Food and Drug Administration (FDA), Good Clinical Practice (GCP), International Committee on Harmonization (ICH), ISO, etc). Organizational awareness to operate in cross-functional teams and provide leadership to other clinical staff members. Effective communication and time management skills required. Must commit to work in a safe environment that is quality- and customer-focused. Must recognize and commit to a sense of urgency, teamwork. Must be able to take and maintain initiative. Possess strong interpersonal skills with the ability to interact with peers, medical professionals, consultants, and Regulatory Agencies as required. Must be able to plan, problem solve with the use of critical thinking skills. Principal Responsibilities Design, implement, manage, and terminate clinical trials. Manage clinical studies and ensure they are carried out in accordance with the Protocols, Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's) and other regulatory requirements. Collaborate in the development, approval, and distribution of study-related documents including study protocols, informed consent documents, study plans, study manuals, and other study tools to investigational sites and review committees. Prepare and participate in presentation of protocols and other study requirements at study initiations at investigational sites when needed. Must have the ability to monitor on-going compliance to study protocols and site adherence to global regulatory guidelines. Oversee subject screening and enrollment at assigned clinical sites, track enrollment. Manage the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness. Assist in the planning, preparing, and distributing of materials for investigator and coordinator meetings, and for study related training. Track and report progress of studies including patient enrollment/screening, patient accountability, device accountability, etc. Management of various clinical study contractors including selected contract research organization (CRO) staff and contract monitors (domestic and international) Provide mentoring to junior staff regarding protocols and site management. Assist data management with the development and review of Case Report Forms for content and ensure proper data is provided for their input analysis and output of reports. Prepare and provide timely reports to management. Develop clinical site training and education and site binders. Maintain registrations on Clinical trial.gov. Review Monitoring Trip Reports provided by Field Monitors. Select and qualify clinical trialinvestigational sites, including managing aspects related to physician relationships, and manage IRB/EC approvals (initial and ongoing). Assist in the distribution of investigational product. Participate in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement. Oversee and participate, as needed, in site close-out visits, report reviews, and follow-up to resolve final site issues. Work with Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.   
Salary Range: NA
Minimum Qualification
5 - 7 years

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