Clinical Data Manager

About the role

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 are completed on time, within budget, and with the highest achievable quality.

Responsibilities

• Communicate key clinical data management metrics (e.g., data entry status, query resolution and aging, etc.) and determine appropriate actions in conjunction with the study team.
• Review, develop, and/or write 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) and Quality Control (QC), as needed.
• Work with the assigned Clinical Database Programmer(s) to ensure the development of Data Flow Chart(s), Data Transfer Specifications, and Import Guidelines.
• Assist with site and/or third-party vendor training on CDM-related topics.
• Provide data review training and guidance to Sr. Clinical Data Coordinators supporting their trial(s).
• Perform data review and discrepancy resolution, as needed.
• Archive trial(s) and associated documentation upon trial completion.
• Ensure adherence to Good Clinical Practice and all applicable local and international regulations.

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 (e.g., 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.

Pay

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 job-related qualifications such as knowledge, skills, education, experience, location, and schedule (full or part-time). 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.