JOB SUMMARY

The Corelab Data Manager provides comprehensive data management expertise and efficient, quality data management services that meet Sponsor needs. The Corelab Data Manager is responsible for the study data quality control, data transfer, and data management-related software application and validation.         

RESPONSIBILITIES

• Support and Coordinate with Corelab Data Management team
• Provide support and may act as the Corelab data management contact person to the Sponsor, CROs, vendors, clinical sites, and Data Processors.
• Develop and maintain good communications and working relationships with Clinilabs project team members as well as the Sponsor, CRO, vendor, and clinical site project team members
• Assist with data analysis and formulation of transfer plans and agreements.
• Assist with oversight of Corelab data services clinical trial databases from the study group, creating a common format for all databases for efficient analyses and maintenance of these databases.
• Oversee data management, entry, cleaning, and quality control efforts. Extract and analyze data on request for the study group.
• Develop Data Validation Specifications (DVS) and User Acceptance Testing (UAT) scripts, test the programs, and work with the developer to resolve all findings before releasing into production.
• Data cleaning activities, including data review and query generation, and reconciliation.
• Responsible for integration of external data from vendors or other departments into the clinical trial database.
• Work with the other functional groups (e.g., Clinical Operations, etc.) to ensure data management aspects of the project are properly considered and integrated well with the other activities.
• Train data managers and/ or coordinators on project-specific data management processes and QC processes.
• Database Quality Control activities and database Lock.
• Create a running inventory/list of common formulations/calculations for most commonly utilized research analyses.
• Develop, edit, and review Standard Operating Procedures and Work Instructions as needed.
• Conduct Corelab Data Service software application validation, change control, and user acceptance testing.
• Follow and ensure compliance with current Good Clinical Practices (cGCPs).
• Adhere to corporate policies and procedures.
• Other duties as assigned.

TRAVELING

Not required. This is a remote position.

Salary Range: $75,000.00-$80,000.00 annually.  Final compensation is based on skills, experience, location and overall expertise.

•  The position requires at least a bachelor’s degree in a scientific discipline, although an advance degree is preferred. 
•  Experience in Data Management with a strong focus on delivering datasets and reports to customers. 
•  Ability of patterns recognition of data discrepancies and root cause diagnosis and suggest possible solutions for data managers or developers.
•  Thorough knowledge of various concepts of statistics concepts, and strong ability to map the related variables/algorithms from Data Transfer Agreement to actionable plans for data mining and data quality control. 
•  Experience of supporting Clinical Data Management Systems to include ECG, EEG, PSG, MWT, and other Corelab Data types and the underlying acquisition systems.
•  Comprehensive experience with user acceptance testing (UAT), edit check development and/or programming and validation; management of data entry and queries; and protocol change control.
•  Familiarity with the Data Management tasks, such as data validation, User Acceptance Testing (UAT), Data Specifications, and Data Transfer Agreements (DTA) 
•  Familiarity with FDA regulations, Good clinical practice (GCP), International Conference of Harmonization (ICH), Clinical Data Interchange Standards Consortium (CDISC), and other guidelines.
•  Fast learner for variable protocols, variable data structures, variable data analysis algorithms, and variable data quality control plans.
•  Familiarity with computer software development life cycle, experience performing software application validation and change control.
•  Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction.
•  Experience in training users in the operation of clinical trials software and tools. 
•  Python, SAS, or SQL programming is a plus.
•  Good Documentation skills and strong team spirit