Job Description

BASIC SUMMARY

Perform the execution of Clinical Data Management functions with delegated authority. Interactively participate in the day-to-day development of the client deliverables while providing supervision and mentorship to Data Management Interns.

Essential Duties And Responsibilities

• Review study-specific documentation as part of the project team to obtain understanding of study-specific data processing conventions.
• Prepare data for entry through completion of transmittal verification, data tracking, and completion of manual review processes.
• Perform data entry in any clinical data management system used by Clinical Data Management.
• Reconcile project files and other documents generated in data management against a database for accuracy and completeness of data management processes.
• Investigate and resolve data anomalies.
• Identify the need for and generate data queries at any point during data processing, based on guidelines set forth in the Data Management Plan (DMP).
• Issue and review queries for completeness and forward to the project lead or designee.
• Conduct quality control including case report form to database review processes.
• Create test data, perform testing procedure of entry screens, and provide test results to the project lead or designee.
• Work concurrently and accurately on multiple protocols.
• Execute all coding activities involved with developing and maintaining a clinical trials database for analysis and/or transfer to sponsor.
• Provide functional oversight of data processing activities including training of staff performing data entry, data cleaning and quality control tasks.
• Report routine project status and data trends to project lead or departmental management as required.
• Create case report forms in accordance with the protocol and established standards when necessary.
• Author portions of or totality of the DMP as required.
• Serve as resource for project lead and departmental management.
• Assist in staffing assignments for assigned projects, ensuring that the project is sufficiently staffed with qualified personnel and specific project requirements are met.
• Provide functional management and supervision of specific projects tasks, as well as conduct timely and through evaluation of work performance of all direct report personnel.
• Assist in providing in-house instruction and mentorship as part of technical career development for Data Management Interns, including training, progress assessment, and facilitate technical development for direct report employees.
• Perform all other related duties as assigned.

Qualifications

• Education: Associate’s degree (A.A./A.S.) or equivalent in a scientific, computer, or related discipline. Bachelor’s degree preferred.
• Experience: 1 year related experience in clinical data management.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: None.
• Experience with relational databases and clinical data management systems
• Demonstrated knowledge of the conduct of general data management and data management quality control activities for a clinical study
• Ability to read, write, speak and understand English required.

Physical Demands

• While performing the duties of this job, the employee is regularly required to talk, hear, type/work at a computer.
• Specific vision abilities required by this job include close vision and the ability to adjust focus.

Work Environment

• General office working conditions, the noise level in the work environment is usually quiet.

Comments

• Must have a valid driver’s license with no limitations on driving availability.

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