Clinical Data Manager 2

asrcfh; United States; Remote; USD 85,000 - 110,000; Full time

Job summary

Agile Decision Sciences LLC is seeking a Clinical Data Manager to support the growing team. You will oversee the data lifecycle across multiple projects, ensuring accuracy and compliance with GCP, GLP, and SOPs.

Responsibilities include QA/QC, database and form design, data abstraction, report development, and ongoing client communication to keep projects on track. A bachelor’s degree and 2 years of related experience are required.

Qualifications

• Bachelor's degree required.
• 2 years of experience in a related or applicable field, or an equivalent combination of education and experience. Experience in Medical, Clinical 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.
• Independent quality control and quality assurance tasks on all projects.
• Ensure compliance with federal regulations, Good Clinical Practice, Good Clinical Data Management Practices, SOPs and Working Instructions.
• Manage patient protocol information and review protocol to incorporate protocol-specific guidelines into trial data review.
• Contribute to database and form design to meet data entry and reporting requirements.
• Test new processes and systems for data management in clinical trials.
• Test clinical trial databases and data entry screens for protocol and institutional compliance.
• Process, track, and validate data accurately and on time.
• Perform data abstraction and data entry on multiple protocols into several databases.
• Develop and extract patient clinical data reports for publications and presentations.
• Proficiency with clinical databases and report tools.
• Identify project-specific reports and assist in their development.
• Prepare, review, and submit clinical data to monitoring agencies.
• Maintain client communication regarding data management project status.

Education

Bachelor's degree

Job description

Agile Decision Sciences LLC is looking for a Clinical Data Manager to support the growing team.

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

Requirements:

• A bachelor’s degree
• 2 years of experience in a related or applicable field, or an equivalent combination of education and experience. Experience in Medical, Clinical or Research environment.