What Does a Clinical Data Manager Do?
When someone is diagnosed with a disease or condition, that individual wants to do everything they can to get better. Many people turn to the medical industry, and it’s up to those in the field like clinical data managers (CDMs) and others to make sure patients’ needs are met through any number of means: treatment, research trials, or other recommendations.
Clinical data management is a career path that allows you to work with medical data. These professionals are responsible for compiling research and trial information to be presented in reports. They may also help present information at conferences or other events. This job requires computer skills, writing abilities, an understanding of clinical data analysis concepts, knowledge of statistical techniques, interpersonal abilities, and more.
For example, if a doctor orders chemotherapy for a patient to treat cancer, CDMs are responsible for overseeing data collection and processing during the treatment, so physicians can see if it’s working or not. If it is progressing as expected, they might recommend additional therapies or medications based on these findings to help subdue the disease.
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National Average Salary
Clinical data manager salaries vary by experience, industry, organization size, and geography. To explore salary ranges by local market, please visit our sister site zengig.com.
The average U.S. salary for a Clinical Data Manager is:
Clinical Data Manager Job Descriptions
When it comes to recruiting a clinical data manager, having the right job description can make a big difference. Here are some real world job descriptions you can use as templates for your next opening.
We are seeking a clinical data manager for our team to ensure that we continue to provide all patients with high-quality, efficient care. The clinical data manager will support the data management group from study start-up through database lock and clinical study reports. They perform complex clerical and office tasks involving the maintenance and/or analysis of clinical data and reports. The incumbent will also abstract relevant information from medical records or perform other related duties as assigned.
Typical duties and responsibilities
- Review protocols and coordinate study set-up activities for trials
- Assisting in compiling data (collected by others) for reports or trial protocols
- Organizing databases/tables for data analysis
- Discussing results of analyses with others, including physicians
- Developing plans to help improve standard operating procedures or efficiencies
- Create calendar specifications for data collection
- Training new employees on how to perform their job duties
- Performing clinical reviews of medical records, especially when searching for patient inclusion/exclusion criteria in research studies
Education and experience
- Bachelor’s degree in healthcare or a related field
- Some experience with clinical trial research and/or data collection
- Ability to apply statistical knowledge and skills to the analysis of complex data sets
- Knowledge of clinical research procedures and regulations
- Ability to type a minimum of 40 wpm
- Experience with Microsoft Office Suite, especially Word and Excel
Required skills and qualifications
- Meticulous attention to detail
- Strong organizational skills
- Ability to work independently without supervision
- Ability to prioritize tasks and handle multiple projects at once
- Knowledge of clinical research procedures and regulations
- Computer skills, especially with Microsoft® Office programs
- Ability to communicate effectively (both verbally and in writing)
- A clear understanding of the benefits of clinical trial research
- Experience with data collection and processing
- Familiarity with research study designs, especially randomized controlled trials
- Understanding of clinical trial phase types
- Ability to work 40 hours per week
- Knowledge of medical terminology
- Experience with creating electronic documents for research reports or trial protocols.
The Clinical Data Management Specialist contributes to clinical trials (CT) through leading Data Management (DM) activities such as: defining the entire data workflow, building, and maintaining clinical data bases, training end users, collecting, handling and storing clinical trial data and ensuring their quality and integrity at a global level following applicable procedures and regulation. They work closely and independently with both internal and external clinical trials partners such as Clinical Scientists, Biostatisticians, and clinical sites personnel.
- Lead and/or coordinate complex clinical trials as needed
- Attend CT kick off and is a key actor of the CA element team. Provides data management inputs for CT protocol writing
- Initiate data management activities for each project : share proposal for future data bases design, highlight issues and specific needs. Ensure that timelines for data management activities is appropriate for CT
- Build and maintain data bases based on the requirements from CT protocol. Follow appropriate procedures to ensure that data bases are well validated and meet CT needs
- Complete the monitoring plan with CS and Biostatisticians based on the monitoring strategy. Develop programs, customized reports or equivalent to cover monitoring needs along the CT
- Train data bases end users: prepare the training support and ensure the training is delivered accordingly before CT start. Ensure good traceability for the training
- Manage data reviews and queries along the CT. Prepare and communicate reporting for CA element team members based on monitoring strategy. Including performing intermediate analyses as needed
- Organize closure activities linked to data management following applicable procedures and prepare data bases for future analysis as needed. Develop and update data management training modules. Train CA new arrivals at a global level.
- Contribute to develop trainee(s) and apprentice(s) in Data Management
- Assist Management for continuous improvement initiatives and special projects. Translate tools enhancements, new processes in operational guidelines and training support, and train end users accordingly. Ensure follow-up/maintenance for each enhancement
Education and experience:
- Bachelor preferred in Data Management/Bioinformatics or equivalent, with a minimum of 3-5 years post degree relevant experience preferred
Skills and qualifications:
- Analytical thinking/flexibility, team work, technical problem solving, ability to explain, quality focus, good communication skills, etc.
- Knowledge of Electronic Data Capture (EDC system), programming language (e.g. SAS)
- Knowledge of Relational data bases including knowledge of SQL language, Cloud solution, Tableau, and Python is a plus
- Ability to Train and educate
- Excellent communication ability both, written & verbal
- Excellent organization skills
A Clinical Data Manager is an expert in clinical data management with demonstrated capability in building and maintaining clinical trial databases. They contribute to process improvements and initiatives within the Biometrics department as well as mentor and train junior staff members as applicable.
You will be responsible for…
- Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner
- Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. Serve as a database manager for the study-specific clinical team, including the compilation of edit checks
- Develop database requirements for use by EDC vendors. Serve as a study database manager and work with vendors to obtain deliverables in a timely manner
- Create and/or review study-specific data management and database documentation, which may include:
- Data Management Plan
- CRF Completion Guidelines
- Coding Guidelines
- Annotated CRFs
- Edit Check Specifications
- Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends
- Perform data review and query generation/closure
- Perform coding of verbatim terms such as adverse events and concomitant medications. Collaborate with medical scientists for coding, consistency, review, and approval. Incorporating coding file into the clinical database
- Participate in the development of new processes or revision of existing processes
- Train internal colleagues in clinical data management in either informal or formal settings as needed
- Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed
- Provide data management expertise and support to the clinical teams using data management best practices
- Provide analytical insight on data management strategies and advise the internal team with tactical strategies accordingly
- As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. Train junior staff in more complex clinical data management processes
What skills and experience you’ll bring to us…
- Bachelor’s Degree in Science or related field
- 2-5 years of clinical data management experience
- Oncology and RECIST experience strongly preferred
- Working knowledge of Clinical Research, Good Clinical Practices (GCP), and regulatory requirements/guidelines
- Experience working with EDC clinical databases
- MedDRA and Who Drug coding experience
- Knowledge of CDISC/STDM standards
- Excellent English verbal and written communication skills; good organizational and interpersonal skills
ABC Company is seeking an experienced Clinical Data Manager who will thrive in a quickly scaling clinical trial technology environment. The clinical operations team at Abc Company is deeply collaborative, and you will work with nearly every function at the company to oversee clinical trial data and set priorities to ensure that all data management procedures are executed on time and to the client’s specifications.
What you’ll do
- Serve as the primary point of contact, internally and externally, for all aspects of clinical data management on assigned projects
- Work closely with others on the clinical operations team to ensure quality execution and client satisfaction
- Collaborate with Clinical Project Managers to create, review, and maintain timelines related to clinical data management deliverables
- Provide estimates of data management resource needs for assigned studies
- Accountable for all clinical data management deliverables (e.g., data management plan, configuration specifications, validation plan, training materials) per the established scope and timeline
- Review assigned protocols and apply specified guidelines to the collection, processing, review and cleaning of data
- Develop and implement study-specific data transfer agreements, when applicable
- Ensure that, from a clinical data management perspective, projects are performed in accordance with the protocol, SOPs, relevant regulatory requirements
- Design trial database and create documentation (edit check specifications, data transfer plan, data management plan, coding plan)
- Responsible for performing user acceptance testing on database applications and data transfers
- Review, analyze, and query data when inconsistencies are identified
- Perform medical coding and medication coding
- Perform activities associated with database lock and data delivery
- 5+ years of experience working in clinical research with at least two years of experience in a clinical data management role
- 2+ years in a lead capacity.
- Comprehensive knowledge of effective clinical data management practices.
- Proficiency with CDASH standards, SAS, a variety of EDC platforms, systems integrations (e.g., EDC-IRT), MedDRA and WHODrug coding
- Knowledge of GCP and relevant regulatory guidelines
- Startup experience
- Previous experience with decentralized clinical trials
- Relevant certification (e.g., CCDM)
Candidate Certifications to Look For
- Medical Statistics Professional Certificate (Stanford). This certificate allows candidates to explore statistical concepts and techniques commonly utilized in medical research, including fundamentals of probability and statistical inference, and basic programming in R or SAS.
- Microsoft Office Specialist. Pass an exam in a specific Office program to earn a Microsoft Office Specialist certification. Being certified as a Microsoft Office Specialist demonstrates the skills needed to get the most out of Office. This is important as many CDMs will work on Microsoft programs.
- Google Data Analytics Certificate. A professional certificate from Google will show candidates have the understanding of analytics that are needed for this position. Learn job-ready skills that are in demand, like how to analyze and process data to gain key business insights.
Sample Interview Questions
- What is your experience with EDC systems and CDMs?
- What steps do you take to ensure that clinical trial data is accurate and complete?
- How did you resolve a data discrepancy in a clinical trial?
- In what ways do you manage study databases and ensure the security of the data?
- What steps do you take to ensure that data collection is completed in accordance with the protocol and that missing data is handled?
- Tell us about a time when you had to implement new data management tools or processes?
- When it comes to clinical data management guidelines and industry regulations, what do you do to stay up-to-date?
- Can you explain your experience with creating data validation rules and edit checks?
- How do you manage data queries and ensure that they are resolved in a timely manner?
- Would you be able to describe a time when you worked closely with a cross-functional team to resolve a data issue?