Data Team Lead

IQVIA; Reading; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading global clinical research organization is seeking a Data Management Associate in Reading. The role involves overseeing clinical data metrics, developing trial documents, and conducting data reviews. Ideal candidates will have at least 5 years of related experience and familiarity with EDC systems. A Bachelor's degree or relevant certification is preferred. Join us to help improve patient outcomes through innovative medical treatments.

Qualifications

• Minimum of 5 years of data management experience required.
• Experience with Electronic Data Capture (EDC) systems is required.
• Oncology and/or inflammatory therapeutic area experience preferred.

Responsibilities

• Communicate key clinical data management metrics.
• Develop and review clinical trial documents and manuals.
• Perform data review and discrepancy resolution as needed.

Skills

Data management

Communication of clinical data metrics

User Acceptance Testing (UAT)

Quality Control (QC)

Education

Bachelor's degree or certification in related field

Tools

Electronic Data Capture (EDC)

Oracle Inc.'s Inform EDC

Job description

Job Overview

Participate as the primary data management representative on the client's multidisciplinary project teams and ensure effective communication exchange.

Essential Functions

• Responsible for communicating key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determining appropriate actions in conjunction with study team.
• Responsible for the review, development and/or writing of clinical trial documents and manuals, including but not limited to Case Report Forms, Edit Checks, Data Management Plans, Clinical Data Review Plans and eCRF Completion Guidelines.
• Participate in User Acceptance Testing (UAT), as needed.
• Participate in Quality Control (QC), as needed.
• Responsible for working with the assigned Clinical Database Programmer(s) to ensure the development of the Data Flow Chart(s), Data Transfer Specifications and Import Guidelines.
• Assist with site and/or third-party vendor training on CDM-related topics.
• Responsible for providing data review training and guidance to Sr. Clinical Data Coordinators that are supporting their trial(s).
• Perform data review and discrepancy resolution, as needed.
• Responsible for archiving trial(s) and associated documentation upon trial(s) completion.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations

Qualifications:

• Minimum of 5 years of data management experience is required.
• Bachelor's degree OR certification in a related allied health profession from an appropriately accredited institution (i.e. RN, MT, PA, RT) is preferred, but individuals with commensurate experience will be considered.
• Experience with Electronic Data Capture (EDC) system(s) is required.
• Experience with Oracle Inc.'s Inform EDC system is preferred.
• Oncology and/or inflammatory therapeutic area experience is preferred.
• Project management experience (within Data Management) is preferred.
• Work history at a Clinical Research Organization (CRO) or CRO management experience in data management is preferred.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com