Clinical Data Manager II / III

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Join Our Pioneering Clinical Research Team as a Clinical Data Manager

At Atlantic Research Group (ARG), a leading Contract Research Organization (CRO) known for its expertise in oncology, immunology, and neurology clinical trials, we are on the lookout for a dedicated Clinical Data Manager II / III to enhance our project teams. This role is central to ensuring excellence across various functional areas including Data Management, Clinical Operations, Safety/Medical Monitoring, and Biostatistics.

Role Overview: Clinical Data Manager

If you are rigorous, adept at multitasking, and excel in both autonomous and collaborative settings, this position could be your next great opportunity. As a Clinical Data Manager at ARG, you will:

  • Independently review protocols and interpret them to establish essential endpoints for clinical database construction.
  • Act as the primary point of contact for sponsors and external vendors throughout the study lifecycle from startup to closeout.
  • Develop Database Specifications and program specs in EDC alongside Clinical Data Programmers.
  • Implement and manage Clinical Data Management Plans (DMPs) and eCRF guidelines.
  • Design, maintain, and oversee the transition of databases into production, including annotated eCRFs, database specifications, and edit checks.
  • Handle Data Transfer Agreements (DTAs) with external data vendors and manage laboratory data integration.
  • Ensure the application of randomization schemes and compliance with SOPs and WIs.
  • Coordinate with CRA teams for query resolution, data reconciliation, and ensuring database integrity for statistical review.
  • Maintain and manage budget forecasts, data quality audits, and database locks/unlocks as necessary.

Who Should Apply?

Ideal candidates will have a BA or BS in a bio-scientific field, healthcare, or life sciences, backed by at least two years of experience as a Clinical Data Manager. We seek individuals with:

  • Proven data management and clinical decision-making abilities.
  • Familiarity with Federal Regulations, ICH/GCP, and relevant SOPs.
  • High proficiency in MAC iOS, ARG Clinical Trial Management System, and Microsoft Office Suite.
  • Strong organizational skills, exceptional attention to detail, and capabilities for both independent and team work.

Work Location and Flexibility

This role offers flexibility with the option to work remotely. Preference is given to candidates within driving distance to our Charlottesville, Virginia office, facilitating occasional on-site collaboration and engagement.

Why Choose Atlantic Research Group?

At ARG, we are committed to driving meaningful clinical research outcomes and value the hard work of our team members. We promote an environment of curiosity and continuous learning, offering competitive benefits, including a generous profit-sharing plan. We embrace diversity and inclusion, striving for a workplace where everyone feels they belong.

Ready to Apply?

If you are eager to advance your career in clinical research and make significant contributions at a company that champions innovation and teamwork, apply today to join our team at Atlantic Research Group. We are excited to see how your skills and passion align with our goals.

ARG is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.