Lab Clinical Data Coordinator (R1090931) in Durham, NC at IQVIA™

Date Posted: 7/31/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/31/2019
  • Job ID:
    R1090931

Job Description

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.

PURPOSE

Provides clinical lab data support as part of a team to develop and maintain Laboratory Data Management (LDM) for the studies awarded to Q2 Solutions EA Genomics and meet 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.

RESPONSIBILITIES

  • Under supervision, 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.
  • Ensure specification and related documentation are filed and stored according to company policy.
  • Understand and verify error logs generated by data formatter programs and communicate to the programming/support team to resolve any issues in data formatting (with guidance).
  • Record all evidence of the data transmission process from data file definition to closure of study.
  • Perform comprehensive quality control procedures to maintain the completeness, accuracy and consistency of deliverables on an ongoing and repetitive basis.
  • Facilitate data entry, compilation, and/or data formatting through established standards and procedures to support projects.
  • Provide input to Sr. Lab Clinical Data Analyst or management relative to project details, e.g., timelines.
  • Contribute project support to the Lab Data Management team.
  • Perform other duties as directed by the functional manager.
  • Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • 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
  • Working knowledge of Linux
  • Working knowledge of programming and text transformation tools, such as VBA, sed, awk, R
  • Exposure knowledge on various regulatory requirements such as FDA, ICH, ISO HL7, and GCP

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1090931