Clinical Data Manager

Summary:

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.

Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.

Typical Duties

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.

Duties include:

• 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
  studies.
• 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.
• Study Closure: 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.

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.
• Demonstrated experience working in and fostering a diverse faculty, staff, and student environment or commitment to do so as a staff member at VCU.