IQVIA Senior Lab Data Analyst in Research Triangle Park, North Carolina
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
To provide clinical lab data expertise as part of a team to develop and maintain laboratory Data Management for studies awarded to Q Squared Solutions-EA Genomics and meet the external client data reporting needs.
This involves capturing data delivery requirements, creating and signing data transfer agreements (along with DTS/DIA documents), managing the project data delivery timelines, formatting of custom delivery files, verification of regulated study data, supporting multiple delivery methods and aiding in the development of custom formatting software, if applicable, and consistent compliance with established systems and workflows.
Able to work within regulatory constraints and comfortable with a high degree of uncertainty, rapid timelines, balancing multiple projects of both short and long-term outcomes. High level of attention to detail, comfortable in a client-facing role and proactive at gathering information across teams, troubleshooting and resilience, and ability to adapt to shifting priorities a must.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:
• Excellent organizational, communication, and computer skills (MS Word, Excel, PowerPoint, and Project, text editor such as Notepad ++ or Sublime, relational database experience preferred SQL)
• Ability to exercise excellent attention to detail
• Highly motivated with a flexible attitude, willingness to proactively seek process improvement, and ability to multi-task
• Ability to establish and maintain effective working relationships across internal teams, with managers, and clients. Troubleshoot and solve problems within established standards and procedures. Perform quality control review on data, send data to clients, and facilitate or draft data transfer specifications documents, Work Instructions, SOPs or other pertinent documents. Guide planning of projects and data management as a team.
• Leads and manages the delivery of projects through full data management study lifecycle, from setup to delivery and reconciliation
• Works with customers, scientific team, data managers and internal team members to manage issue escalation, workload projections, and provide technical expertise
• Provide operational input into proposals and scope of work. Attend customer meetings and lead discussions of project requirements and strategic planning. Understand scope of work, budget, and scope assumptions.
• Strong knowledge of various regulatory requirements such as FDA, ICH, ISO HL7, CFR, Part 11, CAP/CLIA and GCP (Good Clinical Practices).
• Good understanding of medical, clinical research, and Lab Data Management processes and terminology.Qualifications:
• Bachelor's Degree Clinical, Biological Sciences, Computer Sciences or related field
• 3+ years of relevant work experience. Equivalent combination of education, training and experience.
• Excellent written and oral communication skills. Experience writing SOPs, Work Instructions, and Process Flow Charts preferred.
• Excellent organizational and problem-solving skills and demonstrated ability to manage multiple projects of varying complexity.
• Clinical laboratory experience OR Computer Science with Software Configuration and Validation experience preferred
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IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.