Clinical Data Manager

IQVIA; Durham (NC); On-site; USD 69,000 - 171,000; Full time

Job summary

IQVIA is a leading global provider of clinical research services. The Clinical Data Manager performs activities for Phase I-III trials in line with ICH/GCP, ensuring data management from a data perspective is timely, within budget, and of high quality.

The role includes communicating data metrics, writing CDM documents, participating in UAT/QC, working with programmers on data flow, training site staff, reviewing data, and archiving trials while maintaining GCP compliance.

Qualifications

• Minimum of 5 years of data management experience.
• Bachelor's degree or allied health certification; commensurate experience considered.
• Experience with Electronic Data Capture (EDC) systems.
• Experience with Oracle Inform EDC preferred.
• Oncology and/or inflammatory therapeutic area experience preferred.
• Project management experience in Data Management preferred.
• CRO or CRO management experience preferred.

Responsibilities

• Communicate key clinical data management metrics with study team and determine actions.
• Review, develop and/or write CDM documents including CRFs, edit checks, and DMPs.
• Participate in UAT and Quality Control as needed.
• Collaborate with data programming to develop data flow charts and import guidelines.
• Assist with site and third‑party vendor CDM training.
• Provide data review training 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

EDC systems

Oracle Inform EDC

Oncology experience

Project management

CRO experience

Education

Bachelor's degree or allied health certification

Tools

Inform EDC

Job description

Job Summary

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

• 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 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

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe

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.

The potential base pay range for this role, when annualized, is $68,500.00 - $171,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.