| Business Analyst with Clinical Data Management (CDM)::Remote at Remote, Remote, USA |
| Email: shivi94gir@gmail.com |
|
https://h1.nu/161Il https://jobs.nvoids.com/job_details.jsp?id=2125158&uid= Business Analyst with Clinical Data Management (CDM) We are seeking a Business Analyst with expertise in Clinical Data Management (CDM), Medical Imaging, and Contract Research Organizations (CROs) to support and optimize clinical trial data processes. This role will focus on gathering and analyzing business requirements, ensuring regulatory compliance, and enhancing data management workflows for clinical research. Key Responsibilities 1. Requirement Gathering & Analysis Collaborate with clinical operations, data management, and imaging teams to gather and document business requirements. Translate user needs into functional specifications for clinical data management systems (CDMS) and imaging platforms. Work closely with cross-functional teams including biostatisticians, medical monitors, and data managers. 2. Clinical Data Management (CDM) Support Define and optimize CDM processes, including CRF (Case Report Form) design, EDC (Electronic Data Capture) systems, and data validation checks. Assist in the selection, implementation, and validation of CDMS tools such as Medidata Rave, Oracle InForm, or Veeva Vault CDMS. Ensure compliance with CDISC standards (SDTM, ADaM) and regulatory requirements such as 21 CFR Part 11, GCP, and ICH guidelines. 3. Medical Imaging & Data Integration Work with medical imaging teams to integrate DICOM/PACS systems with clinical trial workflows. Define requirements for AI/ML-based image analysis pipelines in clinical trials. Ensure imaging data integrity and compliance with FDA, EMA, and MHRA guidelines for clinical imaging studies. 4. CRO & Vendor Management Liaise with CROs, imaging core labs, and third-party vendors to ensure smooth data exchanges and protocol compliance. Review and optimize CRO contracts, SLAs, and performance metrics. Participate in UAT (User Acceptance Testing) for new clinical systems and software enhancements. 5. Process Optimization & Reporting Develop and maintain SOPs, best practices, and data governance policies for clinical trials. Support clinical trial reporting and analytics by defining KPIs and data visualization needs. Identify opportunities for automation and efficiency improvements in clinical data workflows. Key Qualifications & Skills Experience: 5+ years in clinical data management, medical imaging, or CRO operations. Industry Knowledge: Strong understanding of clinical trial lifecycle, regulatory requirements, and CDM processes. Technical Skills: Familiarity with EDC systems (Medidata Rave, Oracle InForm, Veeva Vault), SAS, Python/R (for clinical data analysis), and imaging standards (DICOM, PACS). Regulatory Compliance: Knowledge of FDA, EMA, ICH-GCP, 21 CFR Part 11, and GDPR. Project Management: Experience with Agile or Waterfall methodologies, JIRA, and Confluence. Soft Skills: Excellent stakeholder communication, problem-solving, and analytical thinking. Preferred Certifications Certified Clinical Data Manager (CCDM) Medidata Rave/Oracle InForm Certification PMI-PBA (Professional in Business Analysis) This role is ideal for professionals looking to bridge the gap between clinical research, technology, and data-driven decision-making in life sciences. -- Keywords: artificial intelligence machine learning rlang information technology Business Analyst with Clinical Data Management (CDM)::Remote shivi94gir@gmail.com https://h1.nu/161Il https://jobs.nvoids.com/job_details.jsp?id=2125158&uid= |
| shivi94gir@gmail.com View All |
| 09:59 PM 29-Jan-25 |