Job Description

JOB DESCRIPTION Job Overview Provide comprehensive clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (LDM) tasks for the studies awarded to Q squared solutions and meets the external client data reporting needs. May be required to support the development of new systems and processes related to the electronic data transfer process, or the configuration of business rules and master data in study and laboratory information systems. Understand and comply with core standard operating procedures and working instructions. Essential Functions . Capable of taking up, independently or providing inputs for, SAS programming activities pertaining to ongoing study requirements or any other adhoc projects in the department . Create and/or review all appropriate data management documents . Understand and comply with core standard operating procedures and working instructions . Develop and maintain good communications and working relationships with LDM team. Serve as back-up for other Data Team Leads . Interact with internal and external team members to negotiate timelines and responsibilities . Train and mentor junior staff in DM expertise . Ensure service and quality meet agreed upon timelines and deliverables in data transmission agreements. Ensure quality checks performed on data files before transmission and obtain peer-review where required. Review own work for accuracy and completeness . Record all evidence of the data transmission process from data file definition to closure of study . Ensure that all specification and design documentation are filed and stored according to company policy . Ensure the internal and external customer queries are timely addressed and resolved effectively . 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 . Local Lab/External Lab role specific: . Serve as Local/External Lab Lead for global studies, which includes being the primary local lab contact for customers, CRAs, and site monitors . Acts as resource for researchers, Medical Technologist, Clinical Laboratory Scientists, Medical Laboratory Technicians and/or Assistants in the technical area to resolve data questions . Provides scientific and technical advice and communicates appropriately to ensure delivery to the customer\'s satisfaction, on time and within budget . Develops formal documentation for position as required by operating procedures, many of which outline specific requirements for managing local lab data . Manages the delivery of projects through full data management study life-cycle, from setup to lock . Supports the identification and resolution of service level issues, as well as the proactive development of contingency plans to mitigate laboratory risk . Works with customers, scientific team, data managers and internal team members to manage issue escalation, workload projections, and provide technical expertise . Interacts and communicates with internal and external customers to ensure that timelines are met and that data is delivered following company guidelines and regulatory compliance . With guidance, manages project timelines and quality issues, and identifies and justifies out-of-scope client requests . Assists internal team with data entry, review and validation of laboratory reports, and serves as back-up contact when needed . Performs comprehensive quality control and edit check procedures . Supports service delivery with comprehensive process and technical expertise in executing projects which includes identifying and resolving issues. Effectively works on corrective and develop preventive action plans 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 . 2-3 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. . For Local Lab/External Lab role: additional 2 years of relevant work experience in a (clinical) laboratory. . Good customer-focus perspective with skill to guide customer communications and customer management. Good attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change. Good project and task management capabilities and ability to manage multiple projects and tasks simultaneously. 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. Proficiency in Windows operating systems (user-level skills), Microsoft Office applications. Good understanding of medical, clinical research, and Lab Data Management process and terminology. Working knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices). Good customer-focus perspective with skill to guide customer communications and customer management. Good attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change. Good project and task management capabilities and ability to manage multiple projects and tasks simultaneously. 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. Proficiency in Windows operating systems (user-level skills), Microsoft Office applications. Good understanding of medical, clinical research, and Lab Data Management process and terminology. Working knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices). Q Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

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