Clinical Data Manager 2

ASRC Federal; Town of Texas (WI); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Agile Decision Sciences LLC is seeking a Clinical Data Manager to support the growing team. You will manage the delivery of high-quality data from start-up through closeout on multiple projects and ensure compliance with federal regulations and SOPs.

Responsibilities include data abstraction and entry, quality control, database design, and developing reports for publications. A bachelor’s degree and at least two years of related experience are required.

Qualifications

• Bachelor’s degree required.
• 2 years of experience in a related or applicable field (Medical/Clinical/Research) preferred.

Responsibilities

• Manage the delivery of high-quality data from start-up to closeout on multiple projects.
• Perform project-specific quality control and quality assurance tasks on all projects.
• Ensure compliance with federal regulations, GCP, GDMPs, SOPs and Working Instructions.
• Manage patient protocol information and integrate protocol-specific guidelines into clinical data review.
• Contribute to database and form design to meet data entry and reporting requirements.
• Test new data management processes and systems for clinical trials.
• Test databases and data entry screens for protocol compliance and procedures.
• Process, track and validate data accurately and on time per instructions.
• Perform data abstraction and entry for multiple protocols into various databases.
• Develop and extract patient data reports for publications and presentations.
• Identify project-specific reports and assist in their development.

Skills

Quality control

Quality assurance

Data management

Education

Bachelor's degree

Tools

Clinical databases

Report tools

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.