Clinical Data Managers

15-2051.02

Apply knowledge of health care and database management to analyze clinical data, and to identify and report trends.

Occupation-Specific Information

Tasks

• Design and validate clinical databases, including designing or testing logic checks.
• Process clinical data, including receipt, entry, verification, or filing of information.
• Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
• Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and work flow processes.
• Monitor work productivity or quality to ensure compliance with standard operating procedures.
• Prepare appropriate formatting to data sets as requested.
• Design forms for receiving, processing, or tracking data.
• Prepare data analysis listings and activity, performance, or progress reports.
• Confer with end users to define or implement clinical system requirements such as data release formats, delivery schedules, and testing protocols.
• Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
• Analyze clinical data using appropriate statistical tools.
• Evaluate processes and technologies, and suggest revisions to increase productivity and efficiency.
• Develop technical specifications for data management programming and communicate needs to information technology staff.
• Write work instruction manuals, data capture guidelines, or standard operating procedures.
• Track the flow of work forms, including in-house data flow or electronic forms transfer.
• Supervise the work of data management project staff.
• Contribute to the compilation, organization, and production of protocols, clinical study reports, regulatory submissions, or other controlled documentation.
• Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices.
• Train staff on technical procedures or software program usage.
• Develop or select specific software programs for various research scenarios.
• Provide support and information to functional areas such as marketing, clinical monitoring, and medical affairs.

Technology Skills

• Access software - Citrix cloud computing software
• Analytical or scientific software - Electronic data capture EDC software; IBM SPSS Statistics 🔥; Oracle Remote Data Capture; SAS ; SAS JMP
• Categorization or classification software - Autocoders; Drug coding software
• Data base management system software - Relational database management software; Teradata Database 🔥
• Data base reporting software - Oracle SQL Loader; SAP BusinessObjects Crystal Reports; SAP Crystal Reports
• Data base user interface and query software - 5AM Glassbox Translational Research; ClearTrial; Clinical trial management software; DZS Software Solutions ClinPlus; ePharmaSolutions eMVR; Fortress Medical Clindex; InforSense InforSense; Invivo Data EPX ePRO Management System; KIKA Veracity; Medidata Rave Data Management; Merge Healthcare eTrials; Microsoft Access 🔥; Microsoft SQL Server 🔥; OpenClinica; Oracle Clinical; Patient tracking software; PercipEnz Technologies OnCore-Clinical Research Management OnCore-CRM; Phase Forward Clintrial; PPD eLoader; Relational database software; Sierra Scientific Software CRIS; Structured query language SQL 🔥; StudyManager Sponsor Edition; SyMetric Sciences SyMetric; TOPAZ Enterprise Software Suite
• Development environment software - Go 🔥; Microsoft Visual Basic 🔥
• Enterprise application integration software - Extensible markup language XML 🔥
• Medical software - Allscripts healthcare automation software; Epic Systems ; MEDITECH software 🔥
• Object or component oriented development software - C# 🔥; C++ 🔥; Oracle Java 🔥
• Office suite software - Microsoft Office software
• Presentation software - Microsoft PowerPoint
• Process mapping and design software - Microsoft Visio 🔥
• Project management software - Microsoft Project 🔥; Project management software
• Spreadsheet software - Microsoft Excel
• Word processing software - Microsoft Word 🔥; Word processing software

Occupational Requirements

Work Activities

• Getting Information - Observing, receiving, and otherwise obtaining information from all relevant sources.
• Monitoring Processes, Materials, or Surroundings - Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.
• Identifying Objects, Actions, and Events - Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.
• Inspecting Equipment, Structures, or Materials - Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.
• Estimating the Quantifiable Characteristics of Products, Events, or Information - Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.
• Judging the Qualities of Objects, Services, or People - Assessing the value, importance, or quality of things or people.
• Processing Information - Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
• Evaluating Information to Determine Compliance with Standards - Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
• Analyzing Data or Information - Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
• Making Decisions and Solving Problems - Analyzing information and evaluating results to choose the best solution and solve problems.
• Thinking Creatively - Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.
• Updating and Using Relevant Knowledge - Keeping up-to-date technically and applying new knowledge to your job.
• Developing Objectives and Strategies - Establishing long-range objectives and specifying the strategies and actions to achieve them.
• Scheduling Work and Activities - Scheduling events, programs, and activities, as well as the work of others.
• Organizing, Planning, and Prioritizing Work - Developing specific goals and plans to prioritize, organize, and accomplish your work.
• Performing General Physical Activities - Performing physical activities that require considerable use of your arms and legs and moving your whole body, such as climbing, lifting, balancing, walking, stooping, and handling materials.
• Handling and Moving Objects - Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things.
• Controlling Machines and Processes - Using either control mechanisms or direct physical activity to operate machines or processes (not including computers or vehicles).
• Operating Vehicles, Mechanized Devices, or Equipment - Running, maneuvering, navigating, or driving vehicles or mechanized equipment, such as forklifts, passenger vehicles, aircraft, or watercraft.
• Working with Computers - Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
• Drafting, Laying Out, and Specifying Technical Devices, Parts, and Equipment - Providing documentation, detailed instructions, drawings, or specifications to tell others about how devices, parts, equipment, or structures are to be fabricated, constructed, assembled, modified, maintained, or used.
• Repairing and Maintaining Mechanical Equipment - Servicing, repairing, adjusting, and testing machines, devices, moving parts, and equipment that operate primarily on the basis of mechanical (not electronic) principles.
• Repairing and Maintaining Electronic Equipment - Servicing, repairing, calibrating, regulating, fine-tuning, or testing machines, devices, and equipment that operate primarily on the basis of electrical or electronic (not mechanical) principles.
• Documenting/Recording Information - Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
• Interpreting the Meaning of Information for Others - Translating or explaining what information means and how it can be used.
• Communicating with Supervisors, Peers, or Subordinates - Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
• Communicating with People Outside the Organization - Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
• Establishing and Maintaining Interpersonal Relationships - Developing constructive and cooperative working relationships with others, and maintaining them over time.
• Assisting and Caring for Others - Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.
• Selling or Influencing Others - Convincing others to buy merchandise/goods or to otherwise change their minds or actions.
• Resolving Conflicts and Negotiating with Others - Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.
• Performing for or Working Directly with the Public - Performing for people or dealing directly with the public. This includes serving customers in restaurants and stores, and receiving clients or guests.
• Coordinating the Work and Activities of Others - Getting members of a group to work together to accomplish tasks.
• Developing and Building Teams - Encouraging and building mutual trust, respect, and cooperation among team members.
• Training and Teaching Others - Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.
• Guiding, Directing, and Motivating Subordinates - Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.
• Coaching and Developing Others - Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.
• Providing Consultation and Advice to Others - Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.
• Performing Administrative Activities - Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.
• Staffing Organizational Units - Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.
• Monitoring and Controlling Resources - Monitoring and controlling resources and overseeing the spending of money.

Detailed Work Activities

• Evaluate data quality.
• Create databases to store electronic data.
• Prepare data for analysis.
• Analyze data to identify or resolve operational problems.
• Develop procedures for data management.
• Monitor operational activities to ensure compliance with regulations or standard operating procedures.
• Develop procedures for data entry or processing.
• Prepare analytical reports.
• Collaborate with others to determine design specifications or details.
• Analyze health-related data.
• Evaluate utility of software or hardware technologies.
• Recommend changes to improve computer or information systems.
• Communicate project information to others.
• Document operational procedures.
• Prepare instruction manuals.
• Supervise information technology personnel.
• Manage documentation to ensure organization or accuracy.
• Update knowledge about emerging industry or technology trends.
• Train others in computer interface or software use.
• Design software applications.