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 patient’s 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 a combination of skills, including computer skills, writing abilities, 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 they 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
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
- 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)
Sample Interview Questions
- Tell me about your experience as a CDM.
- What are some challenges you faced in this role?
- What do you enjoy most about your position?
- How would you handle a difficult situation between a colleague and a client?
- Define the different phases of clinical trials.
- What do you think is the most important part of managing client relationships?
- What is meant by Masking or Blinding?
- How would you handle a situation where the directions given to you by your manager were incorrect?
- What is bioequivalence?
- What is your greatest strength and weakness?
- Do you believe that your background has prepared you enough to be a CDM in this company?
- Do you have any concerns about your ability to handle this position?
- Why do you feel like this is the perfect fit for you?
- Tell me about some of your past projects.