Clinical Data Manager

About the Position

The Clinical Data Manager will support the coordination of multi-site study protocols through Electronic Data Capture (EDC) system management, design and testing, development and execution of data queries, as well as data sharing agreements. This position works cross organizationally to ensure data quality, resolve data discrepancies, confirm data management practices adhere to stringent regulatory requirements, and document standard operating procedures.

About the Project

The primary purpose of this study is to evaluate the safety and tolerability of percutaneous intra-tendinous injection of Purified Exosome Product (PEP) in participants with mid-substance Achilles tendinopathy.

Salary Range

$36.06-$45.67. Salaries are determined based on several factors including external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position.

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 inestigate 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