Atlantic Research Group (ARG), a distinguished Contract Research Organization (CRO) specializing in oncology, immunology, and neurology clinical trials, is seeking a Clinical Data Manager. This role is crucial in providing data management support to Data Management, Clinical Operations, Safety/Medical Monitoring, and Biostatistics functional areas, and to their assigned project teams and team members.
Are you detail-oriented and capable of managing multiple aspects of data management in clinical trials? Do you excel at both independent work and collaboration with teams? If you have the skills and experience we are looking for, consider joining our team.
Key Responsibilities:
- Proficient protocol reviewer, able to read and interpret independently to create necessary endpoints to build clinical databases.
- Lead study from Start up to Close out acting as sponsor and external vendor point of contact.
- Write Database Specifications and program specs in EDC with Clinical Data Programmer
- Implement and oversee Clinical Data Management Plans (DMP) and eCRF guidelines.
- Design and maintain annotated electronic Case Report Forms (eCRF), database specifications, edit checks and move databases into production.
- Create and manage Data Transfer Agreements (DTAs) with external data vendors.
- Local and Central Laboratory normal range processing, loading and merging
- Application of randomization schemes to study databases
- Ensure compliance with SOPs and WIs, contributing to DM department meetings.
- Coding, medical history, medications, and other pertinent clinical/safety data reconciliation.
- Resolve queries and discrepancies, work closely with CRA team and sites while maintaining a working knowledge of regulations, guidelines, and new pertinent technologies.
- SAE reconciliation
- Maintain and forecast budgetary requirements, project and complete activities according to work orders.
- Database quality control audits
- Review of final data listings
- Independently perform task related to database lock/unlock, freeze/unfreeze, and final lock as appropriate for statistical review and interim review.
- Review of final reports
- Project Management
- Other tasks as required.
Qualifications:
- BA or BS in a bio-scientific field, healthcare, or life sciences, or equivalent work experience.
- At least two years experience as Clinical Data Manager required. The level (II or Senior) will be assigned to the hired candidate based on experience.
- Competent data and clinical decision-making skills, and sound judgment.
- Current and working knowledge of Federal Regulations, ICH/GCP, and applicable SOPs.
- Proficiency with computer systems such as MAC iOS, ARG Clinical Trial Management System, and Microsoft Office.
- Strong organizational skills and attention to detail, with the ability to work independently and in a team environment.
Location:
This is a flexible, remote-capable role with a preference for candidates located within driving distance to our Charlottesville, Virginia office.
Why Choose ARG?
ARG prioritizes meaningful outcomes and celebrates those who drive projects to success. Our culture promotes curiosity, teamwork, and lifelong learning. Enjoy competitive benefits, including a generous profit-sharing plan, in recognition of your contributions to our mission.
Diversity and Inclusion:
We are committed to fostering a diverse and inclusive workplace. ARG is an equal opportunity employer, valuing the unique contributions of all team members.
Join Our Team:
If you’re ready to contribute to advancing clinical research and want to be a part of a company that values innovation and teamwork, apply to join ARG.
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