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6-10 years of experience
Successfully designed, developed and implemented clinical trial management systems to support IDE and post-market studies
- Managed implementation of clinical study payments to sites from requirements gathering to development and deployment using Clindex
- Streamlined case report form payment approval process by simplifying reports and eliminating paper approval forms
- Provided support of electronic data entry to principal investigators and study coordinators worldwide
- Collaborated with clinical trial teams to develop and maintain databases for clinical study data collection and analysis
6-10 years of experience
Managed Core Measure abstraction and reporting to insure Joint Commission (JCAHO), Centers for Medicare and Medicaid Services (CMS) and Blue Cross / Blue Shield (BC / BS) compliance. Sole responsibility for running and disseminating quarterly core measure summary and failure reports to appropriate Vice Presidents, Directors and Physician Committees.
- Launched Core Measure Abstraction Program to satisfy new JCAHO, CMS mandate.
- Abstracted clinical data from medical record and electronic health record using pre-existing criteria into online tool.
- Provided Core Measure guideline expertise on 34 core measures sets to Physician Committee and Performance Improvement staff which improved scores up to 19%.
- Identified opportunities for operational and clinical improvements resulting in reeducation of professional staff and changes in documentation patterns.
- Advised front line managers and directors of failures or patterns and recommended corrective action to be implemented.
- Reduced physician referral time through initiation of addition of detailed reason for each failure in summarized core measure report.
- Trained new RN Analyst in Core Measure abstraction for completion of additional required measure sets.
- Increased overall validation score to >90% through review of all CMS Clinical Data Abstraction Center validation charts (5 per quarter) to assure all necessary documents were included.
- Condensed new Core Measure changes into a standard report so clinical and IT changes could be instituted prior to start up date.
0-5 years of experience
Reviewed CRF’S for completeness, accuracy and consistency in accordance with applicable procedures.
- Defined edit checks for the study/project.
- Performed data coordination activities and data validation on CDM projects.
- Assisted User Acceptance Testing before Go-live. Activities included enrolling subjects, collecting feedback and facilitate re-testing of failed scripts.
- Identified and addressed data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Performed Discrepancy Management including manual and system query generation, sending queries to the sites, reviewing and closing the answered queries.
0-5 years of experience
Evaluated large volumes of patient data concerning Vulvodynia and its treatment.
- Analyzed results. Coordinated and executed experiments and assessed results.
- Designed and carried out clinical evaluation, analyzing results upon completion.
- Submitted specimens and data to collaborating laboratories and ensured proper storage of samples prior to transfer.
- Developed grant proposal skills and learned various FDA regulations and safety processes for clinical trial work.
- Learned how to accurately evaluate patients, collecting data, analysis and discussions and conclusions of the results.
- Worked with Dr. Bachmann on researches related to women’s health issues and disorders, reviewing studies and articles submitted for publication, writing papers for publication, attending scientific meetings, presenting presentation on scientific meeting and editing chapters.
0-5 years of experience
Conducted manual review and calculated data entry and discrepancy management error rates for paper trials
- Received, compiled, and assessed adverse events with respect to seriousness, relationship to drug product, and local labeling status in order to assign appropriate case reporting status.
- Handled safety data receipt, triage, database entry, coding narrative, and medical review.
- Provided ad-hoc support for safety data-related requests.
- Supported drafting SOPs and work instructions for Pharmacovigilance.
- Gained knowledge in external Pharmacovigilance process audits and inspections, participated in development and implementation of corrective action plans.
- Data Manager for cardiovascular and endocrinology clinical trials; planned and oversaw the conduction of study-specific data management activities including edit check specifications, discrepancy management and successful database locks.
0-5 years of experience
Monitored database stability and quality of data entered for 5K+ transplant and pulmonary hypertension patients in Southern California. Wrote reports for HUB, regional, and national service areas. Worked with pulmonary, gastroenterology, cardiology, and oncology to develop best practices for patients, jobs, and management. Conducted data analysis, interpretation, and report generation to assist in vendor contract negotiations with Centers of Excellence. Prepared ad hoc, regional monthly utilization, and financial management reports.
- Established consistency throughout three HUBs and met user needs and requirements by migrating SCAL database from regional to national database through use of Access and SQL server, and working with biostatistician to accurately represent HUBs and write queries.
- Maintained data integrity, wrote all required reports, and designed new reports using Crystal Reports to effectively meet user needs during migration from Access to Oracle.
- Wrote and facilitated training in user guide specific to HUB and regional requirements.
- Improved department accuracy and teamwork by facilitating staff training and instituting team meetings for transplant associates.
- Authored organization’s first data procedure manual for National Transplant Network.
- Identified clinical staffing needs by coordinating and maintaining database for time and motion study.
0-5 years of experience
Lead and managed an outcomes quality database directed by the American College of Surgeons (ACS NSQIP).
- Analyzed outcome data, developed case studies/summary analyses and projects for quality improvement in various departments and to assess compliance with regulations and standards in various departments throughout the hospital.
- Reviewed multiple medical records; concurrent/retrospective; to substantiate that deadline and accrual requirement is met.
- Participated in the Quality Improvement Committee and weekly mortality/morbidity conferences.
- Educated various departments to provide a more appropriate approach to process improvement resulting in better informed staff, improved quality and delivery of care, better quality of life, and other positive aspects of surgical care services.
- Compiled and analyzed data trending and benchmarking of clinical services to prepare reports and presentation of findings/recommendations for correcting deficiency.
- Proficient with ICD-9 and CPT Codes
0-5 years of experience
Responsibilities include study start-up activities: site feasibility; site selection, coordination of SIVs with key stakeholders. Engaged in resource allocations, setting project timelines, goals. Management of supplies to the sites; different databases for site/study personnel access, including the IVRS system.
- Audited in-house study files, successfully facilitated FDA audit of study documents involving Plavix
- Successfully managed all study maintenance requirements for more than 350 sites under 4 clinical projects running concurrently: IRB submissions, supply chain management, grant payment to sites, resolution of financial issues.
- Initiated and executed Amendments to site CTAs.
- Distributed Investigator Brochure/Amendments and other key documents to sites.
- Organized & chaired site teleconferences for recruitment and retention with Study coordinators & Investigators. Contributed to Clinical Trial Team meetings with Global Clinical Trial Managers (in France) and other sponsors(BMS)
- Conducted study close-out/archiving activities per SOP. Assisted in writing Clinical Study Report. Created and maintained protocol documentation, including study file.
- Managed & reviewed patient data in Oracle, ClinTrial & RDC systems. Issued queries, made database corrections. Created and maintained protocol documentation, ran reports using SQL.
0-5 years of experience
Played a crucial role in managing internal and external resources and maintained timeline to meet required delivery
end-dates.
- Executed early completion of key projects for current clinical trials by performing thorough quantitative analysis for market
- Created new work flows for start-up studies to achieve uniformity while managing multiple projects.
- Successfully investigated and completed outstanding issues in a timely manner by collaborating with multiple site
0-5 years of experience
Assisted start-up in new product development, branding and marketing of innovative medical management system
- Researched and developed drug-disease database to facilitate integration of prescriptions into episodes of care; mapped over 2,000 drug names to ICD-9 and CPT codes corresponding to approved and off-label indications
- Tested new software functionality and provided detailed testing documentation for new product releases
- Coordinated and staffed trade shows and executed direct mail campaigns promoting products and services
- Assisted with the development of company website and promotional materials
0-5 years of experience
Transitioned existing health Access DB to McKesson Home Health Software for Clinical and Agency Management
- Educated and trained end users on computer applications to collect and distribute patient scheduling, billing and payroll data, billing history information in McKesson Empowering Healthcare system.
- Optimized system performance during user data and payroll transaction generation.
- Using Crystal Reports, generated reports that allowed management to make informed decisions based on customer invoices, billing statements, and statistics.
- Customized databases and imported tables from databases to allow users to generate queries and custom reports. Responsible for day to day operation and maintenance of software.
0-5 years of experience
Maintained coherence between CRFS and the organization’s own MS SQL Server based database from study initiation to closure
- Wrote the review guidelines and edit specifications for a Phase II Pulmonary study
- Created test data for database and performed edit validation at the initiation of a Phase III GI study
- Developed queries in SQL and Access to extrapolate requested data in report format from the database
- Liaison to departments regarding data entry and edit guideline issues from pre-database development to post live
0-5 years of experience
Worked with the Chief Clinical Information Officer in the development of business specifications for product enhancement and new product/view design.
- Collected business intelligence from all applicable sources, including but not limited to, internal customers (e.g., customer development, sales, and marketing), national publications and references, regulatory standards and healthcare accreditation guidelines).
- Documented catalogs, cross-references and maintains business requirements and their relationships to the original sources.
- Analyzed requirements from multiple sources and current product data and views and propose enhancements and/or solutions to update product(s) to meet the requirements.
- Collaborated with customer development and sales staff to fully understand customer needs.
- Managed research projects and data documentation projects from conception to completion.
- Discovered, recognized and identified potential areas where new requirements and information is made available that might impact current products/views of the data.
- Managed the process for the IHM Elearning Program and achievement/maintenance of ANCC provider status.
0-5 years of experience
Successfully served as Data Management Project Lead within a team setting, managing all DM activities for Phase I, II, III & IV clinical trials
- Trained DM personnel in department procedures and practices
- Designed, built, tested & documented study databases and edit check programs
- Developed data entry plan and trained data entry staff on its use
- Coded Adverse Events, Concomitant Medications and Medical History
0-5 years of experience
Reviewed protocols, designed case report forms, reviewed case report forms and documented data problems.
- Created and maintained clinical databases by using SAS and CLINTRIAL.
- Developed and maintained SAS programs for edit checking and produced data listings.
- Created queries using SQL*PLUS.
- Monitored the progress of data entry, and modified data entry screen design performed by Clinical Data Technicians.
- Participated in CANDA validation for the Neuromuscular Blocker group.
- Interacted with relevant clinical research personnel.
0-5 years of experience
Utilizing SAS, provided customized statistical tables, listings and graphs for the statistical section of New Drug Applications.
- Designed and assessed statistical analysis tables for efficacy and laboratory values.
- Created SAS data sets from an ORACLE database.
- Interacted with Clinical Research personnel to design and generate laboratory reports for the safety section of New Drug Applications.
- Performed final quality reassurance checks of efficacy data.
- Organized and chaired meetings to coordinate data collecting, handling, and analysis.
0-5 years of experience
Reviewed case report forms generated from clinical trials for completeness and accuracy using edits and current case report forms listings.
- Performed manual and programmatic validation review of all incoming data and case report forms. This included annotate case report forms.
- Generated data clarification forms if data is incomplete, unclear, or discrepant.
- Updated the database through SAS reported daily maintenance updates as a result of the answered data clarification forms (DCF’s) case listing of edits output.
- Analyzed laboratory results for accuracy and completeness.
- Reviewed data management plan daily.
0-5 years of experience
Reviewed case report forms generated from clinical trials for completeness and accuracy using edits and current case report forms listings.
- Performed manual and programmatic validation review of all incoming data and case report forms. This included annotate case report forms.
- Generated data clarification forms if data is incomplete, unclear, or discrepant.
- Updated the database through SAS reported daily maintenance updates as a result of the answered data clarification forms (DCF’s) case listing of edits output.
- Analyzed laboratory results for accuracy and completeness.
- Reviewed data management plan daily.
0-5 years of experience
Meticulously reviewed Case Report Forms (CRFs) in accordance with the clinical protocol, departmental specifications, and ICH/GCP guidelines.
- Generated Data Clarification Forms (DCFs) if data was incomplete, unclear, or discrepant according to the validation specifications of the Data Management Plan (DMP).
- Updated the database and CRFs as a result of answered DCFs.
- Extensive experience with data cleaning, query writing, and query application using Oracle Clinical 4.0.3.
0-5 years of experience
Responsible for study management and data management on multiple clinical trials.
- Managed the workflow of clinical sites world wide to issue data queries and coordinate return of data.
- Collected and reviewed the data of multiple, simultaneous studies and maintained data query results.
- Interfaced between the sites and the sponsor, escalated issues when necessary. Maintained contact lists for study locations. Conducted outreach to sites when needed.
- Collected and reviewed FDA mandated regulatory documents for clinical trial master files.
- Reviewed and gave sponsor approval of sites’ informed consents for each study prior to IRB submission.
- Conducted meetings and other administrative tasks as needed.
0-5 years of experience
Supported statistics and data management, clinical programming, clinical operations, clinical pharmacology, medical writing and regulatory groups as clinical systems administrator
- Redesigned and implemented clinical departments backup infrastructure. This included the implementation of Offsite Storage of critical clinical trial data
- Ensured clinical systems adhered to food and drug administration guidelines as defined by Sarbanes Oxley, CFR Part 11 and safe harbor
- Technical lead on clinical trials systems infrastructure upgrade. Collaborated with team members to upgrade clinical trial data collections system and worked with quality assurance to validate the new system
- Collaborated with site operations and information technology groups to move clinical systems to data center
0-5 years of experience
Evaluated quarterly medical group’s performances to help determine their year-end bonuses.
- Analyzed drug costs for the Pharmacy Quality Management Program.
- Migration of extensive raw files using MONARCH to Access 97 utilizing tables, queries, forms, reports, SQL
- Provided VMS Operating System support.
- Troubleshot and maintained existing MS Access database to Pharmacy Benefit Management Dept.
- Prepared summary reports to provide trend analysis by extracting data to ACCESS, imported to EXCEL and prepared POWERPOINT presentations for management quarterly reviews.
0-5 years of experience
Promoted to Associate Clinical Data Analyst. Developed and maintained data entry screens in ClinTrial 4x environment following established database standards
- Assisted in defining clinical database standards
- Provided input to the development of Case Report Forms (CRFs) to ensure CRFs are designed in accordance with established standards
- Developed data entry guidelines
- Trouble shooted database set up and data validation check testing
- Assisted in data discrepancies resolution and query generation
- Provided training and technical support to data entry personnel
0-5 years of experience
Assisted in implementing (eDM) eData Management Development System software utilized by Clinical Staff to access EMR to manage Clinical Trial Data
- Facilitated a training session and Trained Clinical Data Managers and Analyst on eDM software
- Reviewed and Analyzed EMR, SAS Datasets, Clinical Database, and Clinical Research Forms to ensure an accurate and clean database
- Maintained multiple Clinical Databases simultaneously
- Report and Query Writer using Excel, Relational Database, using SQL with software application (TOAD) Tool for Oracle Application Developers
- Communicate with internal associates and external clients such as Doctors, Clinical Research Investigators, Managers, Clinical Data Analyst, and, or Client Representatives
- Read, Interpret, and Comprehend Standard Operating Procedures (SOP) and Data Management Plan (DMP)
0-5 years of experience
Helped in analyzing phase II and III clinical trial data.
- Organized and analyzed data related to Visual inspection of sterile parenteral manufacturing processes by using statistical and data analysis tools.
- Created and validated tables, graphs and listings for inclusion in clinical study reports and regulatory submissions.
- Review cGMP documentation and assist in Deviation reports, batch production reports and other Analytical Summary Reports.
- Created analysis datasets and helped in performing statistical analysis on raw data to achieve safety and efficacy objectives of the study.
6-10 years of experience
Worked for Chief Medical Officer and Senior Vice President of Penn Health System and Regulatory Director.
- Assisted 7 clinical departments with projects in clinical effectiveness, patient safety, quality improvement, patient satisfaction and denials.
- Built databases to capture data for quality improvement and clinical effectiveness projects.
- Built Excel spreadsheets for nursing staff to collect data for JCAHO projects.
- Trained nursing staff with data collection methods for the nursing department QI projects.
- Built queries and developed reports using multiple large databases including national comparative databases and provided the key stakeholders of different departments with solutions for their own QI projects.
0-5 years of experience
- Abstracted clinical information and reviewed criteria specified by internal and external standards (The Joint Commission & Centers of Medicare & Medicaid)
- Apply coding guidelines to identify qualifying cases for individual Core Measure cases
- Prepared statistical reports based on internal reviews
- Collaborated with multidisciplinary teams to address documentation and interpretation of clinical data
- Educated and trained new employees
0-5 years of experience
- Reviewed case report forms generated from clinical trials for completeness and accuracy using edits and current case report forms listings.
- Performed manual and programmatic validation review of all incoming data and case report forms. This included annotate case report forms.
- Generated data clarification forms if data is incomplete, unclear, or discrepant.
- Updated the database through SAS reported daily maintenance updates as a result of the answered data clarification forms (DCF’s) case listing of edits output.
- Analyzed laboratory results for accuracy and completeness.
- Reviewed data management plan daily.
0-5 years of experience
Generated and resolved discrepancies involving trial data using CT4 database.
- Ensured the quality of clinical trial data as required per protocol.
- Write data queries.
- Interacted with Medical Monitors, Project Statisticians, Systems Programmers and Data Entry Staff.
- Reviewed database specifications; coding of adverse events and concomitant medications.
- Supported and assisted other Clinical Data Associates and Managers working on trials. Provided status reports, as requested, on the progress of trial.
- Managed the resolution of discrepancies and associated activities within data management for assigned centers, including resolving data entry errors and applying self-evident corrections, and generating DCF’s.
- Incorporated changes resulting from manual review of data listings and updated the Clin Trial database with DCF resolutions.
- Performed SAE resolutions.
- Promptly met the team’s deadlines to ensure data lock.
- 3rd party data reconciliation (i.e. Labs, ECG, IVRS), SAE reconciliation.
0-5 years of experience
Reported directly to Chief Financial Officer and supported daily financial responsibilities including data analysis, statistical research, and various special projects.
- Maintained and distributed monthly financial reports to CFO and CEO.
- Collaborated with sales/marketing manager to produce brochure for new product campaigns.
- Conducted off-site product research and analysis of marketing strategies.
0-5 years of experience
Oversaw day-to-day clinical data management project activities, coordinating with the Data Project Manager, document receipt and control staff, and data entry personnel
- Ensured all CRFs and accompanying documents are tracked, logged, entered, adjudicated, and cleaned in a timely fashion and within the structures of our standard operating procedures
- Spearheaded study setup including CRF design, database structure, annotation, document creation and/or approval, data entry screen and edit check testing and approval
- Participated in presentations to clients, sites, and cross-functional groups
- Provided project manager with regular updates on project progress pertaining to data management activities
- Assumed full project management responsibility on smaller studies
- Mentored data management project staff
0-5 years of experience
- Served as lead Clinical Data Analyst on a number of Phase 1 Clinical Studies
- Created annotated case report forms and data validation manuals
- Generated queries to resolve discrepant and missing data
- Ensured consistency and integrity of data by performing manual review of data listings
- Tested system for accuracy, usability, and performance
0-5 years of experience
- Managed and maintained databases of clinical research data using MySQL 5.5 and accessed through using tools written in PHP 5.3, HTML 5, and CSS 3.
- Data-mining of clinical research data.
- Developed and performed statistical analysis using Matlab 7.12 and JMP 10.0 statistical software.
0-5 years of experience
Generated and resolved discrepancies involving trial data using CT4 database.
- Ensured the quality of clinical trial data as required per protocol.
- Write data queries.
- Interacted with Medical Monitors, Project Statisticians, Systems Programmers and Data Entry Staff.
- Reviewed database specifications; coding of adverse events and concomitant medications.
- Supported and assisted other Clinical Data Associates and Managers working on trials. Provided status reports, as requested, on the progress of trial.
- Managed the resolution of discrepancies and associated activities within data management for assigned centers, including resolving data entry errors and applying self-evident corrections, and generating DCF’s.
- Incorporated changes resulting from manual review of data listings and updated the Clin Trial database with DCF resolutions.
- Performed SAE resolutions.
- Promptly met the team’s deadlines to ensure data lock.
- 3rd party data reconciliation (i.e. Labs, ECG, IVRS), SAE reconciliation.
0-5 years of experience
- Developed a comprehensive database integrating biological, chemical, and financial data into profiles of individual drugs and pharmaceutical companies
- Resolved data discrepancies and inaccuracies to ensure consistency and quality
- Created customized business information reports and drug profile reports
- Designed and delivered marketing presentations resulting in increased sales of reports to corporate and government clients
0-5 years of experience
Provided input on data collection section of Clinical Investigation Plan (CIP)
- Translated CIP into Case Report Form requirements
- Partnered with development team on Clindex Database build, UAT and production
- Participated in data entry, discrepancy management and DCF tracking in Clindex Database system
- Performed in-house monitoring and query resolutions of case report forms (CRFs)
- Coordinated with coordinators/investigators to get the discrepancies resolved
- Participated in data analysis (basic descriptive statistics using graph pad, ANOVA, logistic regression)
- Extracted dataset from several clinical trials for meta-analysis and assisted in manuscript/poster writings
0-5 years of experience
Managed database of pulmonary fellowship programs and determined rates of lung disease incidence and prevalence.
- Using raw data, calculated age-adjusted state-specific lung disease rates with Excel, published statistical reports for national and international distribution.
- Assisted national media outlets, e.g. NBC with statistical data inquiries.
- Work used as the basis for increased national attention to sharply elevated inner-city asthma rates.
0-5 years of experience
- Reviewed highly complex clinical research data to assure compliance with project-specific plans and contracts
- Drove problem solving with clients, statisticians, project managers, physicians and other team members to ensure accurate and timely resolution of issues
- Assisted in development of project plans for data review processes and ensured compliance of all team members involved in data quality activities
- Contributed to the establishment of study timelines and milestones using MS Project and other tracking tools
- Contributed to development of project-specific and departmental quality assurance documentation
- Developed project-specific training documentation and administered training to clients
- Mentored and trained new and/or junior data management staff as required
0-5 years of experience
- Scanned and indexed all case report forms into the Integic System
- Generated and resolved queries
- Integrated data from updated case report forms and received DCFs
- Assisted in Quality Control audits
- Updated the Clinical Tracking Database
- Assisted in other data management duties as assigned
0-5 years of experience
- Maintained electronic databases for hospital administration consisting of performance measures data collected throughout the entire hospital.
- Prepared weekly, monthly, and quarterly reports for senior hospital administrators to track hospital performance measures and provide feedback on performance outcomes.
- Created many electronic databases and personal reports for senior administrators upon request.
- Provided regular follow-up and maintenance on all databases as required.
0-5 years of experience
Reviewed and cleaned eCRF data on large multiple sclerosis study
- Generated, reviewed and integrated queries
- Generated listings utilizing Integrated Review
- Reconciled external lab data and CRF data
- Provided recommendations, test and perform QC on newly developed edit checks
- Performed Database User Acceptance Testing
0-5 years of experience
Reviewed and implemented SOPs (Standard Operating Procedures)
- Reviewed CRFs for inconsistencies and identified items that require clarification
- Served as back up to Senior Clinical Data Analyst for project specific tasks
- Assisted in creating clinically appropriate edit specifications
- Annotated CRFs with database specifications in accordance with global and local standards
0-5 years of experience
Data Implementation Team member for phase III and IV trials for Cox II Inhibitor and Singulair Studies.
- Ensured accurate case report form data entered into the Merck propriety system, paying special attention to adverse events and lab data.
- Correlated lab values to clinical adverse events in the database to streamline reporting.
- Performed checks to identify protocol violations for Inclusion/Exclusion criteria.
- Reviewed entered data for quality control.
- Made appropriate changes from queries into the database.
- Generated queries from various checks programmed into the database.
- Performed remote data capture user acceptance testing for newly designed data handling software. Reported updates at various project team meetings.
- Worked with Laboratory Coordinators, Programmers, Physicians, in house CRA’s, and various other members of the clinical team to maintain data integrity on an ongoing basis.
0-5 years of experience
Generated and closed queries or apply self evident corrections to the data according to the relevant guidelines.
- Reviewed data listings on a monthly basis to find error and issue queries to ensure data accuracy.
- Performed early and final database QC activities.
- Attended training to comply with the SOP of each project.
- Assisted with locking or unlocking the subjects whichever has inconsistent data, to be questioned to the sites and to be discussed with CRA’s.
- Participated in the Project Team meetings to address issues, provide status of the data cleaning/review and capture project priorities.
- Froze and locked data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
0-5 years of experience
Coordinated and reviewed clinical data for a privately owned and operated Contract Research Organization. Implementation: an independently developed online image (Visual Basic/Access) DBMS. Therapeutic areas: Infectious Disease (urinary, respiratory, and skin & skin structure), Neutropenia, Aphthous Stomatitis and Constipation/Quality of Life Survey.
- Presented DBMS demos to prospective clients to differentiate company capabilities
- Served as trainer for other employees
- Established data processing procedures for the handling of CRFs; designed CRF mock-ups
- Developed Data Review Guidelines; defined entry/review data checks; reviewed protocol drafts
- Reviewed CRFs on-line, auto encoded & manually mapped recorded verbatims to preferred terms (WHOART/WHODRUG); executed site contact phone calls for resolution of CRF data clarifications; developed Access queries list for “back-end” data base clean-up
- Maintained Patient Evaluability Log and payment allocation to Investigators
- Executed source documentation and collection of CRFs at investigational site
- Worked with Programming and Biostatistics to execute Analysis Plan specifications and to lock databases
- Addressed ad-hoc requests from Sponsors of microbiological and clinical outcomes and forwarded identification of “patient evaluability” status and protocol exceptions
0-5 years of experience
Served as the team leader on the [company name] project teams and responsible for key project deliverables by developing and performing data checks on the clinical data in accordance with the study specific guidelines to ensure validity, performed quality control activities and ensured all necessary project documentation was created and filed correctly.
- Ensured that timelines and contracts were adhered to and quality standards were met
- Coordinated daily activities for Clinical Data Analyst
- Performed and initiated workflow, sequence of events and processing for data testing
0-5 years of experience
Responsible for reviewing Case Report Forms from clinical sites for completeness and accuracy by using edits listings, manual review, and other appropriate guidelines.
- Composed and generated Data Clarification Forms if data was unclear, incomplete, or with the Data Management Plan.
- Accountable for updating the computer database with data from the Case Report Forms, answered Data Clarification Forms, patient profiles, and other reports.
- Assisted with database lock activities.
6-10 years of experience
Reviewed case report forms for completeness and consistency
- Generated queries for missing and/or inconsistent data
- Reviewed clinical protocols
- Designed standard case report forms
- Created SAS database and data entry screen using FSP Software
- Created SAS error check program, AE and CONMED auto coding program, Summary Tables and Listing programs
- Customized reporting of data using SAS proc print, proc report, and data null listings
- Maintained in-house dictionary for specific study
6-10 years of experience
As a clinical analyst, I provide operational and clinical business intelligence to regional directors and front line leaders.
- Produce daily/weekly/monthly reports for the Health Services Organization to ensure smooth operations including patient census reports, nurse productivity stats, and clinical metrics
- Create ad hoc reports and analyses for a wide range of internal and external customers utilizing several systems/software including SQL Server, Oracle, Excel and Access
- Documented business and technical specifications for reporting.
- Translated business initiatives into comprehensive reports for management.
0-5 years of experience
Served as point person for day-to-day project activities as back-up to Lead Data Manager
- Performed data review and query generation
- Tracked study progress, distributed reports and generated/compiled data management statistics as relevant to the project
- Assisted in coordinating the work of Associate Data Analysts assigned to the project
- Defined and tested edit checks
- Developed data entry guidelines
- Assisted in CRF development and design
- Interacted closely with Clinical Research Associates (CRA) in dealing with project needs as necessary
Clinical Data Analyst Duties and Responsibilities
The daily duties performed by clinical data analysts vary based on the amount of data they work with, the scope of the databases they manage, and the size of their team. However, there are several core job tasks common to this job, including:
Compile Data
Clinical data analysts gather and compile data for storage inside healthcare databases.
Monitor Data Usage
Clinical data analysts monitor data usage in the database. They conduct analysis find usage trends, spot data patterns, and isolate potential system problems.
Write Reports
Clinical data analysts write reports summarizing and analyzing data on a regular basis, including monthly, quarterly, and year-end reports.
Verify Data
Clinical data analysts verify the accuracy of data to ensure all information is correct.
Coordinate with Staff
Clinical data analysts coordinate with medical and data staff members to learn more about the medical facility’s data needs.
Retrieve Missing Data
Clinical data analysts retrieve missing or lost data as requested.
Expand Database
Clinical data analysts expand databases as needed to facilitate more data storage.
Clinical Data Analyst Skills and Qualifications
Clinical data analysts use analytical and computer skills to study and compile data, isolate potential problems, and maintain clinical databases to ensure information is accurate and easy to access. Employers look for these specific skills when hiring clinical data analysts:
- Computer skills – strong computer skills are essential for clinical data analysts, who compile data, create databases, and analyze information using various software
- Analytical thinking – clinical data analysts use analytical skills to study data and isolate potential problems
- Communication skills – clinical data analysts use written communication skills to write reports; they use verbal communication skills to collaborate with other data management and medical staff members
- Attention to detail – clinical data analysts use strong attention to detail to spot data patterns, monitor data usage, and verify data accuracy
- Organization skills – clinical data analysts use organization skills to build databases and compile data that’s easily accessible to others
- Multitasking – clinical data analysts perform various tasks at once, which requires good multitasking
- Problem-solving – clinical data analysts isolate and solve database and data problems, which requires strong problem-solving skills
Clinical Data Analyst Education and Training
A majority of employers require clinical data analysts to have a bachelor’s degree in computer science, life science, a health-related field, or a similar field of study. Though not required, many employers prefer candidates who have a master’s degree. However, real-world work experience can be substituted for additional education in the eyes of many employers. Little to no training is provided to clinical data analysts, who already have the education and skills needed to perform their regular job duties. However, new clinical data analysts often work closely with the data team supervisor during the first few weeks of employment to become comfortable with the medical facility’s data needs and goals.
Clinical Data Analyst Salary and Outlook
Information from PayScale shows that clinical data analysts earn $62,341 in median annual income. The Bureau of Labor Statistics (BLS) shows that database administrators earn $87,020 in median annual income. Database administrators use software to store and organize data, performing many of the same tasks as clinical data analysts. BLS projections show that these jobs are likely to increase 11 percent through 2026, a rate that is faster than the national average. Most employers provide clinical data analysts with full health insurance coverage that includes medical, dental, and vision benefits. Paid holidays, vacation days, and sick days are typically included in these packages, as are life insurance and retirement planning options. Some medical facilities offer additional perks such as free parking, free meals, and free access to gym facilities.
Helpful Resources
Use these resources to find job listings, learn workplace strategies, browse networking opportunities, and search training and education programs:
Society for Clinical Data Management – find certification programs, online education courses, upcoming networking events, useful publications, job openings, and more content at this website dedicated to clinical data management in all its forms
Practical Guide to Clinical Data Management – this book is an in-depth guide to clinical data management, covering everything from collecting data to analyzing and compiling data – all the skills essential for clinical data analysis
American Health Information Management Association – visit the AHIMA website to find training and education programs, certification courses, career openings, and upcoming conference and event dates for all professionals who work with health information, including clinical data analysts
Clinical Data-Mining: Integrating Practice and Research – learn how to extract, analyze, and interpret data with this book, which provides in-depth information about making decisions and performing other essential clinical data analysis tasks
Association for Clinical Data Management – find training courses, job openings, research resources, articles, and other content for clinical data analysts at the ACDM website
The Fundamentals of Clinical Data Management – read this book to learn the fundamentals of data management and helpful study techniques that will serve any clinical data analyst well
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[Clinical Data Analyst]
Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
