QUALIFICATIONS

Bachelors degree or equivalent work experience required

3-5 years of clinical data management experience desired

Experience with Electronic Data Capture (EDC) systems, quality control, dataset creation and maintenance

Experience using REDCap for data collection/management preferred

Ability to investigate data quality issues and participate in remediation activities

Statistical and data analysis skills are a must to assist gathering and solving data quality issues

Experience in data writing requirements

Intermediate or advanced computer skills including Excel and other Microsoft Software

Excel Macros experience a plus

Demonstrated competence in oral and written communication

Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor

Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner

MANAGEMENT RESPONSIBILITIES

Oversees quality assurance of all study databases, proactively tests data to identify data integrity issues, makes recommendations, and plans solutions based on research goals

RESPONSIBILITIES

Advises on, adheres to, and completes data requirements and plans for the full data life cycle from project conception to long term data storage and usage

Design and modify Case Report Forms (CRFs) in response to IRB modifications and protocol changes

Author and execute comprehensive User Acceptance Testing (UAT) and validation testing plans to ensure database functionality

Defines data edit/validation checks, performs database lock and archive procedures, and establishes database use guidelines

Remotely monitors Clinical Trials data, confirming data accuracy and quality, and reporting to appropriate stakeholders, as needed.

Perform supplemental data reviews and reconciliations to support Adverse Event (AE) and safety monitoring.

Generate and track data queries; work directly with research staff to resolve any issues.

Develops and maintains Data Management Plans (DMP), Standard Operating Procedures (SOPs), and Work Instructions (WI)

Assists with the design of data collection, data privacy and confidentiality plans

Cross-check EDC data against external metrics to verify accuracy and resolve discrepancies

Recommends operating methods to improve processing, distribution, data flow, collection and database editing procedures, working to optimize data quality and automate data collection and management processes

Ensures appropriate data use and/or sharing agreements are executed for each project

Consults with regulatory staff to ensure compliance with all local, federal and Department of Defense specific regulatory policies and procedures

Maintains working knowledge of all military health system data systems and resources to advise investigators on appropriate data for their research goals

Assists researchers in retrieving information from military health system databases and other data sources

Completes other projects and duties as assigned