RQM+

Clinical Data Manager

RQM+

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud PlatformSQL

About the role

  • RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.
  • We don’t make MedTech. We make MedTech happen.
  • Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency
  • The Clinical Data Manager (CDM) is responsible for day-to-day data management operations for RQM+ and its clients; collaborates with the Manager of Clinical Data Operations to provide a proactive approach to data validation from initial set up, through maintenance and into locking / archiving the EDC database.

Requirements

  • Academic background in Science or Biomedical Engineering.
  • Previous Data Management experience for a CRO or in industry – preferably for a Medical Device / Diagnostics company.
  • Good working knowledge of ICH GCP.
  • Proficiency in using multiple EDC platforms.
  • Strong communication and organizational skills.
  • Working knowledge in setting up databases in EDC platforms that may use modules outside of EDC such as Randomization (or RTSM), Labs, ePRO, eConsent, Imaging, and Adjudication amongst others.
  • Working knowledge of SAS and/or SQL programming.
  • Experience working in set up, maintenance and locks for multiple projects in parallel.
  • Working knowledge of MedDRA and WHO DD Coding.
  • Excellent levels of communication and organizational skills.
  • Proficiencies in working independently as well as within an overall team structure.