Research Data Manager
Research Data Manager
There is a large volume of data collected in clinical trials to include research subject data, site-specific, regulatory, and safety data. Proper data management ensures the integrity of the study and is critical for the success of a trial. The Data Manager is responsible for managing data from a variety of clinical research studies and ensuring data is collected, managed, and reported clearly, accurately, and securely. The position will be responsible for proper data management to ensure timely EDC entry, query resolution, facilitate correspondence with sponsors during site visits, help answer sponsor's queries, and provide data directly to the identified data base for each study. May contribute to the creation or development of data management systems.
Required to enter all study and/or research participant data into the Clinical Trial Management System (CTMS) as applicable. Duties include but are not limited to:
- Manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects.
- Demonstrates a general understanding of each assigned protocol, critical tasks and milestones.
- Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
- Assists in the preparation of CRF/eCRF for data collection through the regulatory approval process.
- Works directly with sponsors to ensure data entry, data quality checking, data transfer, reporting, and query resolution.
- Reviews study protocol and assists site coordinators, investigators, and other clinical staff in collecting routine data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves routine queries.
- Process, track, and validate data accurately and on time, in accordance with data processing and entry instructions.
- Perform data abstraction and data entry on several different protocols into multiple clinical research databases.
- Comply with all GUMC and Clinical Trial Management procedures as well as all Medicare compliance procedures.
- Comply with all GUMC training requirements as applicable to position (CITI, COI, ACRP/SOCRA or equivalent, Bloodborne Pathogens, Billing Compliance).
- Attend a minimum of 6 GUMC research meetings (CRN, CROO, LCC) per year.
- Complete and upload time & effort forms on-time each month into designated university Box folder.
- Other duties as assigned.
- Bachelor's Degree in science related field and at least 2 years of related experience
- Competent in Microsoft Word, Excel, Access and PowerPoint
- Strong organizational skills
- Excellent interpersonal, written and organizational communication skills
- Detail oriented with excellent analytical skills
- Ability to maintain confidentiality, prioritize, and meet deadlines
- Experience with web-based Electronic Data Capture (EDC) and clinical data management systems preferred
- Knowledge of data extraction methods
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