Clinical Data Manager
ASRC Federal · Reston, VA · 2 wk ago
Information TechnologyFull-time
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
- 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 clients
- Demonstrate a significant amount of initiative, autonomy, and proficiency in all areas above
Requirements
- A bachelor’s degree
- 2-4 years of experience in a related or applicable field, or an equivalent combination of education and experience
- CIBMTR data management experience
Qualifications
We invest in the lives of our employees, both in and out of the workplace, by providing competitive pay and benefits packages. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law.
Skills
Possess proficiency with clinical databases and report tools
Benefits
The salary offered will depend on several factors including, but not limited to, relevant experience, skills, education, geographic location, internal equity, business needs, and other factors permitted by law.
Schedule
Not specified
Pay
Not specified