Senior Clinical Data Manager: Data Quality & Compliance

Socket.dev; Town of Texas (WI); On-site; USD 70,000 - 90,000; Full time

Job summary

Agile Decision Sciences LLC is seeking a Clinical Data Manager to support a expanding team in managing data for multiple clinical trials from start-up through closeout. The role requires a bachelor’s degree and at least two years of experience in medical, clinical, or research settings, with a focus on data quality, regulatory standards, and collaboration with sponsors.

You will design databases and forms, test systems, perform data abstraction and reporting, and ensure timely delivery while

Qualifications

• Bachelor’s degree is required.
• 2 years of experience in a clinical, medical, or research environment.

Responsibilities

• Manage the delivery of high-quality data from project start-up and planning to project execution and project closeout on several projects.
• Independently perform project-specific quality control and quality assurance tasks on all projects.
• Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
• Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously.
• Contribute to the design of the databases and forms, ensuring they meet requirements for entry and reporting of clinical data of varying complexity.
• Test new processes and systems for the management of data in clinical trials.
• Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures.
• 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.
• Develop and extract patient clinical data reports for publications and presentations.
• Possess proficiency with clinical databases and report tools.
• Identify project specific reports and assist in the development of these reports.
• Prepare, review, and submit clinical data to monitoring agencies.
• Maintain client communication regarding data management project status and review key project questions with client.

Education

Bachelor's degree

Job description

Agile Decision Sciences LLC is seeking a Clinical Data Manager to support a expanding team in managing data for multiple clinical trials from start-up through closeout. The role requires a bachelor’s degree and at least two years of experience in medical, clinical, or research settings, with a focus on data quality, regulatory standards, and collaboration with sponsors.

You will design databases and forms, test systems, perform data abstraction and reporting, and ensure timely delivery while