What are the responsibilities and job description for the GEHC - Clinical Data Manager III position at Axelon?
Data Manager
100% Remote
12 Months
Pay : 107.14 / hr.
Job Description Summary
As a Clinical Research Data Manager, you will be responsible for supporting medical device clinical trials and research through coordinating, facilitating, and participating in all data management activities from initiation of a study protocol, through final data archival. In this role, you will partner with Clinical Operations teams (Study Monitors, Statisticians, System Admin) and Clinical Research Managers to ensure strategic planning, resourcing, execution, and oversight of clinical trial data deliverables.
Essential Responsibilities
- Serve as the primary point of contact for all data management activities for multiple clinical trials across a range of medical devices and program teams ensuring compliance with Good Clinical Practices, ISO 14155 and other applicable regulations.
- Works with Clinical Operations and Clinical Research Managers to ensure data management activities are conducted compliantly and according to project timelines.
- Attends internal and external meetings as necessary to facilitate discussion and decisions for data management strategy pertaining to study, regulatory, or GCP specific requirements
- Develops and maintains study-specific Data Management Documents, such as DMPs, DVPs, CCGs and CRFs based on protocol and study requirements
- Builds clinical trial databases from data specifications, including edit checks, derivations, and Custom Functions.
- Consults and collaborates with the Clinical Research Operations Team to review reporting needs and develops reporting mechanisms
- Keeps management informed on progress and other project related information, assist management in projecting resources, and perform administrative duties as requested.
- Participates in team review and maintenance of QMS work instructions governing Clinical Data Management, always striving to identify and implement opportunities for improvement.
Qualifications / Requirements
Desired Characteristics
