Lab Data Mgr
Job description
Job Overview
Provides expert level clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (LDM) for the studies awarded to the laboratory and meets the external client data reporting needs.
Essential Functions
• Serve as primary point of contact for customer on data management deliverables. Provide project management expertise working with customer data managers and internal team members to manage issue escalation, workload projections, and provide technical expertise. Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources. Establish and maintain strong internal and external customer relationships. Ensure open communications with customer and Company management to manage and meet contractual obligations. Establish strong communications with programming team, functional leads, project managers and all other stake holders to identify, develop and implement project solutions. Support DM service delivery with comprehensive DM process and technical expertise in executing projects which includes identifying and resolving issues. Effectively work on corrective and develop preventive action plans. Serve as the escalation point for unresolved data issues
• work with client data managers and internal team members for resolution. Create and/or review and sign-off on all appropriate data management documents. Implement proactive quality management plans across multiple projects/programs. Track service performance and provide leadership to identify root causes of issues and implement remedial actions. Continuously look for opportunities to improve service
• work with team to develop and implement plan to re-organize and drive change across multiple projects/program (with minimal support). Ensure timely follow-up and resolution of compliance issues. Train and mentor junior staff in DM expertise. Ensure service and quality meet agreed upon timelines and deliverables in data transmission agreements. Participate in and support RFP process (review RFP documents, pricing, may attend bid defense). Serve as back-up for team members. Identification of the database set up and programming gaps and Solves issues through using the global issue escalation/communication policy. Understanding and verification of program generated error logs and communicate effectively to the programming/support team to resolve any data management related issues. Understand and comply with core standard operating procedures and working instructions. Use of multiple communication styles and skill to effectively broker audience specific [peers, senior team members, internal/external customers] business and interpersonal relationships that lead to positive outcomes and successful business results. Perform other duties as directed by the functional manager
Qualifications
• Bachelor's Degree Local Lab/External Lab Role:
Medical Technologist or Clinical Laboratory Scientist degree with clinical laboratory experience
OR Computer Science with Software Configuration and Validation experience Req
• 5+ years of experience in Data Management and SAS Programming. Requires basic knowledge of SAS Programming and Data Management procedures obtained through prior work experience or education. Equivalent combination of education, training, computing qualification and experience.
• Strong customer-focus perspective with skill to guide customer communications and customer management.. Self-driven.
• keen attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change.. Project and task management capabilities to meet/exceed deliverables.. Effective problem solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality.. Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.. Computer proficiency including word processing, spreadsheet and Power Point applications.. Good understanding of medical, clinical research, and Lab Data Management process and terminology.. Knowledge on elicitation of the data requirements and authoring specifications.. Knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices). Strong customer-focus perspective with skill to guide customer communications and customer management.. Self-driven.
• keen attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change.. Project and task management capabilities to meet/exceed deliverables.. Effective problem solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality.. Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures.. Computer proficiency including word processing, spreadsheet and Power Point applications.. Good understanding of medical, clinical research, and Lab Data Management process and terminology.. Knowledge on elicitation of the data requirements and authoring specifications.. Knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices).
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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