What does a Clinical Data Manager do?
Clinical data managers apply their knowledge of healthcare and database management to analyze clinical data and identify trends and report them. They design and validate clinical databases, which could include designing or testing logic checks. They process clinical data, including the receipt, entry, verification, and filing of information to generate data queries after validation checks or errors and omissions identified during data entry. They do this to resolve unidentified problems.
Clinical data managers develop project-specific data management plans that address coding, reporting, transfer data, database locks, and workflow processes. They monitor the productivity and quality of work to ensure it complies with standard operating processes and procedures and prepare appropriate formatting to data sets when requested. They design the forms used in the receiving, processing, and tracking of data. Clinical data managers need a minimum bachelor's degree in health administration and a concentration in mathematical subjects including statistics.
- Support CRF design, review and validation of clinical database.
- Assist with the collection, aggregation and analysis of data.
- Monitor vendor performance to ensure timelines and data quality standards are met.
- Provide training, mentorship and guidance.
- Assist with the administrative and financial management of allocated projects.
- Represent the data management functions in client-facing and internal meetings.
- Assist with goal creation and performance review assessment for data review project staff.
- Lead projects to support process improvement through the use of CIS.
- Incorporate and maintain medical standards in clinical studies for all elements of the medical standards package.
- Share data arrival and cleanup status and metrics with the study team.
- Ensure service and quality meet agreed upon specifications per the DMP and scope of work.
- Contribute to projects and initiatives aimed at improving and optimizing the delivery of DMAR, DSandA, Portfolio and Operations, OSBU.
- Serve as client contact for project meetings and CDM status updates.
- Support the assessment, evaluation and selection of CIS applications.
- Perform a variety of duties relating to Clinical Information Systems (CIS) applications.
- Perform duties in compliance with SOPs, GCP and ICH guidelines in accordance with regulatory, legal and ethical standards.
- Develop and delivers study specific training for DM project staff.
- Serve as a clinical data management expert and provide guidance on CDISC standards.
- Bachelor's or Graduate's Degree in business, nursing, science, or information systems or equivalent experience.
- Experience with ECRF, CRF, SQL, ECTD, SAS, ETMF, and CCDS software and systems.
- Experience with Medidata RAVE.
- Fluency with HIPAA regulations and protocols.
- Demonstrated capabilities with statistics, writing protocols, data transfer, data sets, and spreadsheets.
- Is a leader and critical thinker with strict attention to detail and solid collaboration and problem solving capabilities.
How much does a Clinical Data Manager make near United States?
Clinical Data Manager Career Path
Learn how to become a Clinical Data Manager, what skills and education you need to succeed, and what level of pay to expect at each step on your career path.
Years of Experience Distribution
Clinical Data Manager Insights
“This is the best place where we can scale up our skills and people here are very helpful.”
“Working for Accenture can be a great way to advance your career and build your network.”
“Lots of resources for personal and career development: I got a mentor to answer my questions.”
“Great place to start your career if you want to learn a lot of new things.”
“project on boarding was smooth and quick.”
“Low pay and advancement is not great.”
“People are nice and friendly.”
“Good Great Excellent Fantastic Fantabulous”
Clinical Data Manager Interviews
Frequently asked questions about the roles and responsibilities of a Clinical Data Manager
When working as a Clinical Data Manager, the most common skills you will need to perform your job and for career success are Windows Operating Systems, Critical Thinking, Highly Organized, Annotation, and Relational Database.
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The most common qualifications to become a Clinical Data Manager include a minimum of a Bachelor's Degree and an average of 0 - 1 years of experience not including years spent in education and/or training.
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I’ve been at my org 7yrs. There is a pattern of me inheriting the work of higher level fired employees without a raise. I’m in research w/ an Ops background. They fired our Ops Director ($140k) and gave me some of those duties but said I’m not eligible for a pay raise due to my “emotional intelligence” and that I need to produce more research for a raise. I make ~$80k. Ops is a mess, I have more experience in it than the Director did, and that lane of work is taking most of my time. Advice?