Clinical Data Manager
Job posting number: #7079157
Posted: May 27, 2021
Application Deadline: Open Until Filled
Job DescriptionOrganizational Overview
At VCU, we Make it Real through learning, research, creativity, service and discovery — the hallmarks of the VCU experience. A premier, urban, public research university nationally recognized as one of the best employers for diversity, VCU is a great place to work. It’s a place of opportunity, where your success is supported and your career can thrive. VCU offers employees a generous leave package, career paths for advancement, competitive pay, and an opportunity to do mission-driven work.
Position Primary Purpose and General Responsibilities
The clinical research data manager is responsible for the collection, entry and management of data for multiple projects from multiple Sponsor sources including national, pharmaceutical and Investigator-Initiated Sponsors. The incumbent will work with internal and external study members to
make sure data is collected, managed, cleaned and reported clearly and accurately for all trials assigned to your team. You will report to the Manager, Data Management Core within Clinical Research Operations Unit of the Clinical Trials Office at Massey Cancer Center.
The candidate at the Advanced level (CDM III) will perform the duties listed with minimal supervision as well as serve to train and mentor CDM II/I. You may manage biospecimen and observational
studies in partnership and with support from the Clinical Operations Lead and Study Investigator. The CDM III may also serve as a super user of the DEEP6Ai assisting designated disease specific
study teams to match trials to patient and patients to trials. You may represent the operations team as a clinical operation representative on Disease working Groups and aid in the identification and
recruitment of patients to treatment clinical trials.
Intermediate level (CDM II) will perform the
following job responsibilities under general supervision. The candidate at the Assistant level (CDM I) will perform these responsibilities under direct supervision.
• Project Start-up: Work collaboratively and independently to develop electronic clinical research charts, conduct data retrieval, entry and quality control using eMR, CTMS (OnCore), other IT system
and supporting documentation.
• Test electronic data capture to meet the needs of studies.
• Help with project management and planning for all aspects of data collection and data processing for research
• Ensure trial visits, data for study participant tests and samples are done per the study
schedule and entered in a timely fashion.
• Support the clinical study team coordinator/research
nurse and PI as appropriate.
Study Conduct: Review and resolve data discrepancies with electronic data check systems.
Reconcile internal and external data sources and query and resolve any issues identified. Maintain all data management documentation following standard practice guidelines.
Perform database close and locking procedures.
Perform procedures for archiving research databases.
Finalize data management study data and documentation.
Other responsibilities include: Create and review standard operating procedures.
Three positions will be filled from this posting.
Minimum Hiring Standards
• Assistant level (CDM I): Requires 1+ years of experience in a role that supports data management activities with an exposure to data processes and flow or ability to learn basic data entry, understand
complex protocols and motivation to learn foundation of at least one oncology disease area.
•Intermediate level (CDMII) : Requires an Associate’s degree and 1+ years of experience in data management in a regulatory compliant environment with a working knowledge of data management
processes, data cleaning and flow.
• Advanced and Intermediate level: Experience with EDC
software, XML, onCore, eMR (Cerner or EPIC), RedCap, DEEP6Ai.
• Experience with Microsoft
Excel, Microsoft Word, Visio, Smartsheet and Adobe.
• Ability to work as a team member and
independently; analyze problems in a logical and systematic manner; pay attention to and accurately
execute detailed tasks.
• Effective oral, written, and interpersonal communication skills.