| Looking for Clinical Operations Data Manager Fully Remote at Remote, Remote, USA |
| Email: [email protected] |
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Processing description: http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2161997&uid= From: Sushmita Soni, Sonitalent [email protected] Reply to: [email protected] Hi Hope you are doing well, We are looking for Clinical Operations Data Manager if you are interested kindly send me your updated resume. Job Title Clinical Operations Data Manager Job Location -Fully Remote Duration - 6 Months+ Mode Of Interview - Phone/Skype Note - Need LinkedIn Job Description Key Responsibilities: The Clinical Operations Data Manager is responsible for overseeing and managing clinical trial data to ensure accuracy, compliance, and efficiency. This role involves working closely with clinical teams, data management specialists, and regulatory bodies to develop data collection processes, analyze clinical trial data, and ensure adherence to industry standards and protocols. Data Management & Integrity: Develop, implement, and maintain data management plans for clinical trials. Oversee data collection, cleaning, validation, and reconciliation to ensure accuracy and completeness. Develop and review case report forms (CRFs) and databases Collaborate with clinical research associates (CRAs), investigators, and data entry teams to ensure high-quality data. Database & System Management: Design and maintain clinical trial databases and electronic data capture (EDC) systems, including User Acceptance Testing (UAT). Ensure compliance with regulatory requirements (FDA, EMA, ICH-GCP, HIPAA). Work with IT and software vendors to optimize data systems and resolve technical issues. Compliance & Quality Control: Ensure adherence to Good Clinical Practice (GCP) and other regulatory guidelines. Conduct data audits and implement corrective actions as needed. Develop and maintain standard operating procedures (SOPs) for data management processes. Ensure all clinical data is consistent, accurate, and reliable. Collaboration & Reporting: Partner with clinical operations, biostatistics, and regulatory teams to support study objectives. Generate reports and summaries for internal stakeholders and regulatory submissions. Communicate data trends, discrepancies, and issues to relevant teams for resolution. Serve as the main point of contact for data-related inquiries from both internal teams and external partners Monitor and track clinical data timelines to ensure data is collected and cleaned according to the study schedule. Analyze data trends and report any irregularities to the clinical trial team. Qualifications & Skills: Bachelors or Masters degree in life sciences, healthcare, data management, or related field. 3+ years of experience in clinical data management or a related role in the pharmaceutical, biotech, or CRO industry. Proficiency in EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault, Viedoc). Strong knowledge of clinical trial regulations (FDA, EMA, ICH-GCP). Experience with database programming and query resolution. Excellent analytical, organizational, and problem-solving skills. Strong communication and teamwork abilities. Thanks & Regards Sushmita Soni Sr. Technical Recruiter | SoniTalent Corp. Desk | 859-659-1004 EXT 201 [email protected] Address - 5404 Merribrook Lane, Prospect, KY, USA Keywords: information technology Kentucky Looking for Clinical Operations Data Manager Fully Remote [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2161997&uid= |
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| 04:11 AM 11-Feb-25 |