Clinical Data Manager

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Kaztronix is seeking a Clinical Data Manager to oversee data management for Phase I-III trials in line with ICH/GCP guidelines. The role focuses on delivering high-quality data on time and within budget, coordinating with multidisciplinary teams and ensuring regulatory compliance.

Responsibilities include creating and reviewing CDM documents, performing UAT/QC, coordinating with programmers on data flow specs, training sites, resolving data issues, and archiving study data after trial completion.

Qualifications

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

Responsibilities

• Serve 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 the study team.
• Review, develop and/or write CDM documents and manuals (CRFs, edit checks, DMPs, eCRF guidelines).
• Participate in UAT and QC as needed.
• Work with the Clinical Database Programmer to develop Data Flow Charts and Import Guidelines.
• Assist with site and third-party vendor training on CDM topics.
• Provide data review training and guidance to Senior Clinical Data Coordinators.
• Perform data review and discrepancy resolution.
• Archive trial documentation upon completion.
• Ensure adherence to GCP and applicable regulations.

Skills

EDC systems experience

Data management

Project management in DM

Regulatory compliance (ICH/GCP)

Education

Bachelor's degree or allied health certification

Tools

Oracle InformTM 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

• 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 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 InformTM 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.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.