| Urgent Opening || Clinical Project Manager || Remote at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1691302&uid= From: Prashant Pal, Vbeyond Corporation [email protected] Reply to: [email protected] Hello, Greetings of the day, This is Prashant from VBeyond Corp. We are a global recruitment company with specialization in of hiring of (IT) professionals. One of our clients is looking for Clinical Project Manager at the location Remote Job Description Job Role : - Clinical Project Manager Location : - Remote Duration : - Kong Term Qualifications & Requirements Bachelors Degree in life science, engineering, clinical field or equivalent (associate degree plus four years research experience) years of experience project managing clinical and/or technical research studies in a clinical setting, industry, or government agency. Experience with Clinical trial management, ISO standards, CFR (Code of Federal Regulations) standards. Demonstrated success in projects requiring accuracy with details, documentation, and communication between parties. Desired Characteristics Strong oral and written communication skills. Ability to document, plan, communicate, and execute programs. Demonstrated understanding/experience with Good Clinical Practices, global and regional research regulations, research processes, New Product Introduction (NPI) cycle, and cross-functional interdependencies. Experience working with IRBs and regulatory agencies. Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. Autonomy to make decisions within a defined framework. Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters. What is in it for you As a Research Program Integrator (Project Manager), you will be a part of an Agile team to build healthcare applications and implement new features while adhering to the best coding development standards. Job Description Summary The Research Program Integrator (RPI) is responsible for cross-functional project management of research activities and activities to support External Evaluation efforts. The RPI ls cross-functional planning, tracking, communication of status, and execution of research studies. The RPI manages wing-to-wing execution for research activity defined by the strategic research team through development, management, and closure, while meeting all quality, content, schedule, and budget targets. They will specifically focus on projects within the Fleet Solutions organization. Roles and Responsibilities Manages cross-functional wing-to-wing execution of research activities defined by research managers to meet clients strategic research and External Evaluation efforts, including investigator-initiated studies, internal human subjects research studies, external client-sponsored research studies, and other research-related activities. Develops study documents including study plans, protocols, informed consent documents, and budgets in consultation with Research Managers, business stakeholders, and external investigators. Develops, negotiates, and ensures signature of research contracts, in consultation with Legal counsel, Research Managers, business stakeholders, external investigators, and external research contracting departments. Manages requests for, and facilitates shipment and tracking of, research devices and other research support items. Coordinates or conducts study training and monitoring for Client-sponsored research. Monitors study progress and any applicable adverse events or deviations reporting for client-sponsored research. Collects research deliverables, ensures they are complete in accordance with research contracts, coordinates review and approval by research managers, processes payments. Checks quality and maintains records of research activity in compliance with good documentation practices and documentation management systems and processes. Works across functions (with Research Managers, research operations, engineering teams, service, QA, RA, Medical, and modality team members) to conduct and deliver research activity and results on time, within budget and with the necessary deliverables. Identifies early and raises/helps solve cross-functional execution challenges which may hinder the timely completion of research commitments. Partners with the product team/internal stakeholders for prioritization and changes to study details Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of QMS, SOPs, P, Phased Review Discipline, and all compliance and regulatory requirements of the applicable regions. Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area. Autonomy to make decisions within a defined framework. Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters. Thanks Prashant https://www.linkedin.com/in/prashantpbh/ Keywords: quality analyst information technology Urgent Opening || Clinical Project Manager || Remote [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1691302&uid= |
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| 11:29 PM 24-Aug-24 |