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Lab Data Analyst

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Primary Location: Santa Clarita, California, United States Additonal Locations: Livingston, United Kingdom,GBR Full time R1297689

Job description

PURPOSE 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 Q2 laboratory and meets the external client data reporting needs.

RESPONSIBILITIES

  • 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 3 year of relevant work experience; or equivalent combination of education, training and experience.

PHYSICAL REQUIREMENTS

  • Extensive use of telephone, computer aided, and face-to-face communication requiring accurate perception of speech and clear articulation and idea formation.
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time.

EEO Minorities/Females/Protected Veterans/Disabled

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. https://www.q2labsolutions.com/careers

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/q2-solutions-eoe

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/q2-solutions-covid-19-vaccine-status

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“I know Q2 Solutions offers me a great career path with lots of options. My line manager fully supports my growth.”

Marianne H, Associate Laboratory Project Set-Up Manager

“There are tremendous opportunities to grow here. If you are driven, passionate and committed, the sky’s the limit.”

P. Surve, Clinical Process Team Lead

“What gets me most excited about being part of Q2 Solutions is working with cutting-edge technologies that help patients and further innovation in the field.”

Todd L., Scientist

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