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.
An intermediate level Lab Data Analyst that provides clinical lab data expertise as part of a team to develop and maintain Laboratory Data Management (LDM) for the studies awarded to Q2 Solutions laboratory 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. Understand and comply with core standard operating procedures and working instructions.
The ideal candidate will have SAS or R programming experience
- Manage delivery of projects through full data management study life-cycle with guidance from a more senior Laboratory Data Analyst or Manager, manage project timelines and quality; identify out-of-scope work. Serve as a Primary Laboratory Data Analyst for a number of regional or global studies. Bring project solutions to the LDM team.
- Interact with internal and external team members to negotiate timelines and responsibilities and to help resolve issues dealing with clinical trials database.
- 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.
- Determine and assist with set up data requirements and specifications per project needs as requested by the Client Data Manage; identify database set up and programming gaps and solves issues using the global issue escalation/communication policy.
- Ensure specification and design documentation are filed and stored according to company policy.
- Understand and verify error logs generated by the LIQVIA Data Transmission creation programs and communicate to the programming/support team to resolve any issues in the data transmission (with guidance).
- Record all evidence of the data transmission process from data file definition to closure of study.
- Ensure the internal and external customer queries are addressed and resolved effectively.
- Perform comprehensive quality control procedures to maintain the completeness, accuracy and consistency of the clinical trial database deliverables on an ongoing basis.
- Uses multiple approaches or technologies to solve a problem within established standards and procedures.
- Provide input for negotiations with customer relative to project details, e.g., timelines, financial, process, resources.
- Perform other duties as directed by the functional manager.
- Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.Qualifications
- Bachelor's Degree Computer, life sciences or a related field Req
- 1 year of relevant work experience including programming experience Req Or
- Combination of computing qualification and professional experience Req Or
- Equivalent combination of education, training and experience Req And
- Experience with SAS programming in the course of file format process
- Good customer-focus perspective with skill to guide customer communications and customer management Beginner
- Good attention to detail to anticipate, address and/or escalate issues, with aptitude to embrace and be conduit for change Intermediate
- Good project and task management capabilities and ability to manage multiple projects and tasks simultaneously Beginner
- Effective problem solving skills as well as ability to proactively identifying process improvements which reduce operational costs and maintain quality Beginner
- Quality conscious with high degree of ethics and integrity carrying out duties in accordance to laws, regulatory standards, and with company policies and procedures Intermediate
- Proficiency in Windows operating systems (user-level skills), Microsoft Office applications Beginner
- Good understanding of medical, clinical research, and Lab Data Management process and terminology Beginner
- Working knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GLP (Good Laboratory Practices) Beginner