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.
A 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 Quintiles laboratory and meets the external client data reporting needs.
- Serve as Data Team Lead (DTL) for regional and global studies or serve in a leadership role to a specific DM Task.
- Manage delivery of projects through full data management study life-cycle.
- With minimal guidance, manage project timelines and quality issues, and identify and justify out-of-scope
- Serve as back-up for other Data Team Leads.
- Perform comprehensive quality control procedures.
- Provide input for negotiations with customer.
- Independently bring project solutions to the LDM team
- Identification of the database set up and programming gaps and solves issues through using the global issue escalation/communication policy.
- Understanding and verification of error logs generated by the QLIMS Data Transmission creation programs and communicate effectively to the programming/support team to resolve if any issues in the Data Transmission.
- Create and/or review of all appropriate data management documents
- Understand and comply with core standard operating procedures and working instructions
- Meet objectives as assigned
- Develop and maintain good communications and working relationships with LDM team
- Interact with internal and external team members to negotiate timelines and responsibilities.
- Train and mentor junior DTL staff in DM expertise
- Ensure service and quality meet agreed upon timelines and deliverables in data transmission agreements
- Review own work for accuracy and completeness
- Ensure quality checks performed on data files before transmission and obtain peer-review where required
- 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
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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)
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s degree or educational equivalence in computer/life science or related field with relevant work experience; or equivalent combination of education, training and experience.