| Clinical Data Manager at Remote, Remote, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1321195&uid= From: Komal Gupta, Largeton Inc [email protected] Reply to: [email protected] Job Short Description minimum of 9 years of experience in clinical data management.Job Description Clinical Data Manager Location: MA-relocation is fine(onsite) Dur:6 months Visa: No H1B/CPT Domain: Pharmaceutical Responsibilities: Oversee all aspects of data management throughout the lifecycle of assigned studies, from study initiation to database lock. Lead and manage multiple large and complex studies, ensuring tasks are performed efficiently and delegating responsibilities as needed. Foster effective communication and collaboration with sponsors, vendors, and cross-functional study teams. Provide mentorship and guidance to junior personnel within the data management team. Develop and implement standard operating procedures (SOPs) and study-specific protocols to ensure consistent and high-quality data management practices. Create and maintain comprehensive study documentation, including Data Management Plans, eCRF specifications, and CRF Completion Guidelines. Collaborate with database programmers to design and implement (e)CRFs and edit checks in EDC systems for complex studies. Lead and coordinate User Acceptance Testing (UAT) tasks for EDC systems, ensuring proper functionality and data integrity. Coordinate with sponsors and vendors to facilitate efficient electronic data receipt, integration, and reconciliation. Troubleshoot technical issues related to data management processes and EDC systems. Design customized data review processes and listings to facilitate effective data review and query resolution. Perform coding of adverse events, medical conditions, and medications, ensuring accuracy and compliance with coding guidelines. Lead pre-lock and data lock activities, ensuring timely database closure. Develop training materials and user guides for EDC data collection tools and conduct training sessions for team members and end-users. Participate in client meetings, providing updates on study progress and offering insights on best practices. Generate and review status metric reports, identifying trends and communicating findings to stakeholders. Provide input on project scope changes and assist with resource allocation to meet project milestones. Lead and oversee large and complex projects within the data management domain. Represent the data management team in sales and marketing meetings for prospective clients. Contribute to the development and maintenance of SOPs and manuals related to data management processes. Education and Experience: Bachelor's degree in a scientific or health-related field or equivalent. Minimum of 9 years of experience in clinical data management. Skills: Proficiency in medical terminology and pharmaceutical notation. Expertise in EDC systems, including but not limited to Medidata Rave, InForm, and Medrio. Strong organizational and time management skills. Excellent collaboration and leadership abilities. Regards, Komal Gupta | Technical Recruiter Largeton INC. Herndon, VA 20171 [email protected] Keywords: Massachusetts Virginia Clinical Data Manager [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=1321195&uid= |
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| 08:27 PM 18-Apr-24 |