Clinical Data Manager - FSP (Homebased - UK)

IQVIA; Reading; On-site; GBP 50,000 - 70,000; Full time

Job summary

IQVIA is seeking a Clinical Data Manager to oversee data management activities for Phase I-III trials in accordance with ICH/GCP. You will ensure timely, budget-conscious data delivery with high quality, working with multidisciplinary project teams.

The role requires 5+ years in data management, Oracle Inform EDC experience, and CRO/pharma background. Oncology/inflammatory experience is preferred. This position is based in Reading, UK, with no visa sponsorship.

Qualifications

• Minimum of 5 years of data management experience.
• Bachelor's degree or allied health certification preferred.
• Oracle Inform EDC experience required.
• Oncology and/or inflammatory therapeutic area experience preferred.
• Project management experience within Data Management preferred.
• CRO or Pharma data management experience desirable.

Responsibilities

• Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
• Communicate key clinical data management metrics and determine actions with study team.
• Review, develop and/or write trial documents including CRFs, edit checks, DMPs and eCRF guidelines.
• Participate in UAT and QC activities as needed.
• Collaborate with Clinical Database Programmers on data flow charts and transfer specs.
• Assist with site and vendor training on CDM topics.
• Provide data review training and guidance to Sr. Clinical Data Coordinators.
• Perform data review and discrepancy resolution as needed.
• Archive trials and documentation after completion.
• Ensure adherence to GCP and applicable regulations.

Skills

Data management

Communication

Project management

Oracle Inform EDC

Clinical trial documentation

Quality control

Education

Bachelor's degree

Allied health certification

Tools

eCRF systems

Job description

The Clinical Data Manager performs activities pertaining to the conduct of Phase I-III clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines. The CDM ensures, from a data management perspective, assigned trials on time, within budget, and with highest achievable quality.

Summary of the Essential Functions of the Job

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

Minimum Requirements

• Minimum of 5 years of data management experience
• 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.
• Oracle Inform EDC experience
• Oncology and/or inflammatory therapeutic area experience is preferred.
• Project management experience (within Data Management) is preferred.
• CRO or Pharma data management experience

This role is not eligible for UK visa sponsorship

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.