Clinical Data Manager
Durham, NC - USA
Job Summary
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.
- Bachelors 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
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. 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 $68500.00 - $171100.00. 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.Required Experience:
Manager
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more