CLINICAL DATA SPECIALIST JOB DESCRIPTION

A Clinical Data Specialist keeps structured, regulation-compliant data flowing between patient records and the systems that govern care quality and research outcomes. Few roles demand this breadth. In healthcare settings ranging from CoC-accredited cancer programs to CMS-contracted quality initiatives, this specialist owns the accuracy of abstracted clinical data - ensuring that what enters a registry, trial database, or EMR audit trail can withstand scrutiny from federal, state, and payer agencies. The CTR credential and HIPAA compliance obligations that often define entry into this work signal how seriously the field treats data stewardship at the individual level.

As the Clinical Data Specialist, you will own the collection, validation, and regulatory-compliant reporting of clinical data across registries, quality databases, and trial management systems, directly shaping the integrity of records that inform patient care decisions and institutional accreditation standing. You will operate within quality management, research, or data operations teams - collaborating with clinicians, compliance officers, and external auditors to keep data standards current and defensible.

Career Impact: Mastery of clinical data abstraction under CoC accreditation standards and federal reporting mandates positions a specialist as a high-value contributor in a segment where credentialed data professionals are consistently scarce.

Business Impact: When this role performs well, hospital partners maintain accreditation, quality metrics reach payers accurately, and research datasets hold up to statistical review - failures in any of these carry direct regulatory and financial consequences for the institutions served.

Growth Opportunity: The analytical and governance skills built here - data lineage documentation, registry abstraction, quality audit methodology - open pathways toward Clinical Data Manager, Data Governance Analyst, or senior research informatics roles.

Company Value: Positions in this field frequently offer fully remote schedules with paid onboarding periods, employer-covered CEU time, and access to in-house education teams focused on ongoing credential maintenance.

• Abstract and code eligible clinical cases from unstructured patient medical records against current state mandates and national accrediting agency standards.
• Audit clinical record data on a defined cycle to identify anomalies, documentation gaps, and compliance risks, entering findings into quality databases.
• Validate submitted data across registries and reporting repositories to maintain accuracy thresholds required by federal, state, and payer agencies.
• Develop and update data management documentation including abstraction guidelines, data dictionaries, and quality review protocols.
• Collect and compile data from quality management sources to produce monthly and quarterly performance reports for clinical and administrative leadership.
• Investigate data quality issues and reporting discrepancies, recommending and implementing corrective action within defined timelines.
• Partner with clinical, IT, and compliance staff to support data governance activities including data definitions, lineage documentation, and process improvement.
• Train program staff and junior team members on data collection procedures, abstraction standards, and registry documentation requirements.

• Bachelor's degree in health information management, life sciences, public health, or a related field, or equivalent work experience.
• 2 or more years of clinical data management or health information experience, with direct exposure to registry abstraction, clinical trials, or quality reporting.
• Knowledge of healthcare regulatory and accreditation frameworks governing clinical data, including federal and state reporting mandates.
• Demonstrated ability to audit clinical records for data integrity, identify documentation deficiencies, and escalate findings through appropriate channels.
• Proficiency in data entry, database management, and electronic medical record systems used in clinical or quality management environments.
• Strong analytical and organizational skills with a high threshold for accuracy and attention to detail in documentation-heavy workflows.
• Effective written and verbal communication skills for conveying data findings to clinical, administrative, and external stakeholder audiences.

• Current Certified Tumor Registrar (CTR) credential or active enrollment in a Cancer Information Management program, demonstrating specialization in oncology data abstraction.
• Experience supporting CoC-accredited cancer programs or similar accreditation-governed clinical data environments.
• Familiarity with research Common Data Models or clinical trial data concepts such as CDASH, RECIST, or CRF design and edit check validation.
• Prior involvement in data governance or stewardship activities, including documenting data lineage and prioritizing data quality enhancement requests.

• Case abstraction accuracy rate, measured against internal quality review thresholds and external accreditation audit findings.
• Registry submission timeliness, tracking the percentage of eligible cases entered within mandated reporting windows.
• Data query resolution rate, reflecting how consistently open data queries are closed within defined study or program timelines.
• Audit deficiency rate per review cycle, measuring documentation gaps identified across clinical records reviewed.
• Regulatory submission acceptance rate, tracking first-pass acceptance of data submitted to federal, state, or payer repositories.
• Typical tools: EHR and registry platforms (commonly Epic, Avatar); data management and reporting environments (commonly InForm, Rave, Oracle Clinical).

• Base Salary Range: $55,000 to $80,000 annually, depending on credential and experience.
• Bonus: Discretionary performance bonus, typically 5% to 8% of base salary.
• Equity: Not typical for individual contributor roles in this segment.
• Health Benefits: Medical, dental, and vision coverage; employer contributions vary by organization.
• PTO: 15 to 20 days annually, plus paid holidays and typically paid CEU or education time.
• Common Perks: Remote work options, paid professional development, CEU reimbursement, and employer-supported credential maintenance.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Employment is contingent on successful completion of a background check and, where applicable, drug screening consistent with healthcare industry requirements. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law. Reasonable accommodations are available throughout the hiring process and in the workplace for individuals with disabilities. Candidates must hold valid authorization to work in the United States.

The Clinical Data Specialist owns the abstraction, coding, and quality submission of cancer case data across hospital partner registries, ensuring compliance with CoC Accreditation standards and national accrediting agency mandates. Reporting to in-house quality leadership, this specialist delivers precision-driven registry solutions to hospital partners nationwide while contributing to team best practices, data dictionaries, and the professional development of early-career Cancer Registry Support Specialists.

Key Responsibilities

• Bring specialized knowledge and patient storytelling skills to hospital partners through categorizing, coding, summarizing, interpreting, and mining registry/case information from nuanced, unstructured patient medical records.
• Support partners' CoC Accreditation process with strong cancer registry operations, creation of policies and procedures, utilization of NCBD quality tools, and knowledge of how all the standards support quality patient care.
• Perform data collection (abstracting) and reporting on eligible cancer cases under current state mandates and national accrediting agencies.
• Ensure quality submission of all data in specified registries or measure data repositories, maintaining a high accuracy threshold.
• Contribute to team best practices, data dictionaries, abstraction guidelines, and other business rule documents while identifying process improvement opportunities to help streamline tasks and processes.
• Stay up to date on mandated regulatory/publicly reported data requirements as specified by federal, state, payer, and other agencies.
• Engage in a variety of educational opportunities, including on-the-job learning guided by the in-house Quality and Education Team along with easily accessible CEUs and paid time for continuing education.
• Deliver quality solutions to hospital partners across the country, approaching each hospital engagement as an opportunity to apply expertise with precision.
• Contribute to a culture of perpetual learning and meaningful collaboration, supporting the development of colleagues including early CTRs and Cancer Registry Support Specialists.

Required Qualifications

• Current CTR credential required.
• Graduate of a Cancer Information Management program required.
• Experience working at or with a CoC Accredited facility.
• Ability to evaluate concordance with cancer program accreditation and other applicable standards.
• Exposure to multiple patient medical record systems (EMRs) and clinical databases.
• Strong analytical and critical thinking skills to approach problems in a systematic method, synthesizing data and suggesting recommendations.
• High standards for accuracy and attention to detail.
• Technical savviness and interest in learning new systems and technology.
• Organized and adept at managing time across multiple accounts and shifting timelines and priorities.

Benefit

• W2 employment with a flexible schedule in a 100% remote environment, with no travel or onsite work required.
• Competitive pay with growth and advancement opportunities.
• Paid onboarding while awaiting facility access, along with opportunities to learn new skills through the in-house quality and education department.
• Comprehensive benefits including medical, dental, vision, 401(k) with match, generous PTO, parental leave, employer-paid short- and long-term disability, employee wellness resources, paid education time, and CEUs.

Embedded within the data management team, the Clinical Data Specialist shapes the integrity of clinical trial databases by issuing queries, validating CRF content and edit checks, and maintaining comprehensive DM documentation from Data Management Plan through reconciliation guidelines. Working closely with DM leads, programmers, biostatisticians, and sponsor representatives, this specialist delivers clean, audit-ready datasets while supporting system development, validation, and cross-functional reporting across pharmaceutical and CRO environments.

Core Functions

• Issue queries and review query responses at the highest level of quality based upon the Data Review Plan, Manual Review, Aggregate Checks, and Reconciliation with LAB, SAE, ECG, and other vendors.
• Assist with other data reviews for Biostatistics, Medical Review, Sponsor, and other ad hoc reports.
• Support system development and validation creation.
• Provide input for and draft CRF design, edit check specifications, and DM listings.
• Consolidate comments from internal and sponsor sources for discussion and approval.
• Oversee the entry of data in development or QC systems used for validation.
• Perform validation of data management systems including CRF content, edit checks, associated DM reports or listings, and associated change control.
• Provide feedback to other DMs and Programmers to improve deliverables.
• Create and update DM documentation including Data Management Plan, CRF Completion guidelines, Data Entry guidelines, Trial Design Document, edit specifications, reconciliation guidelines, and report specifications.
• Serve as back-up or primary DM for internal and client team meetings, producing and reviewing metric reports for internal and external project teams.
• Review project budgets and staffing projections for data management activities and provide the DM lead or PM with status updates on assigned tasks.

Qualifications & Experience

• Bachelor's degree in life sciences or equivalent knowledge and experience.
• Minimum 1 year of clinical data management experience in the pharmaceutical industry, contract research organization, or similar industry, with 2 years preferred.
• Knowledge of clinical trials data processing concepts and unique data collection concepts such as RECIST, CDASH, Local Labs, and Adjudication.
• Knowledge of data management processing systems, with preference for InForm, Rave, and Oracle Clinical.
• Proficiency in computer applications including Windows, Excel, Word, and Outlook.
• Ability to create DM study documents such as CRF guidelines, trial design documents, and edit checks.
• Ability to interact with the entire clinical team, including CRAs, Safety, and Biostatisticians, to address data collection concerns.
• Strong interpersonal, verbal, written, and listening communication skills.
• Team player with the ability to work well with technical and clinical team members.
• Organized and thorough with attention to detail and effective logical thinking for problem-solving.
• Willingness to learn new skills and share knowledge with others.
• Ability to accept constructive criticism, adhere to detailed instructions, and work independently.

Reporting to the Director of Quality Management, the Clinical Data Specialist ensures the accurate and timely collection of clinical record data within the Quality Management Department, supporting compliance with licensing, regulatory, and contractual requirements. Partnering with the QM Department team, residential program leadership, and agency QM Committee members, this specialist audits clinical records, tracks documentation integrity, and produces monthly and quarterly performance reports that inform quality improvement decisions.

Primary Duties

• Perform data entry of QM data into the quality database.
• Develop forms and protocols within the QM Department to gather real-time clinical record information.
• Aid in the creation and development of various clinical data reports.
• Audit clinical record data on a regular basis to ensure data integrity, quality, and identification of data anomalies, entering results into databases.
• Aggregate audit data received, identifying all documentation weaknesses and risk trends that have potential to impact licensing, regulatory, or contractual compliance.
• Identify and report data entry errors and omissions immediately to the Director of QM.
• Ensure clinical record confidentiality and HIPAA compliance.
• Track clinical record documentation and audit results submitted by Quality Assurance Specialists.
• Collect, compile, and analyze data from the QM team to measure and report on provider and program clinical record documentation and other record-related performance.
• Create monthly reports for the Director of Quality Management and quarterly reports for the Quality Management Committee.
• Train and update program management staff quarterly on data collection activities.
• Respond physically to client needs in the event of a crisis.

Education & Experience

• Bachelor of Science with two years of experience in health information technology and strong computer skills required, or four years of experience in lieu of the educational requirement.
• Annual TB clearance and First Aid/CPR Certification required.
• Experience in data collection and assessment.
• Familiarity with California Mental Health Medi-Cal residential and Specialty Mental Health Outpatient billable services, documentation, diagnosis, and medical necessity justification preferred.
• Familiarity with California Drug Medi-Cal residential substance use disorder billable services, documentation, ASAM criteria, levels of care designation, and medical necessity justification preferred.
• MH and Drug Medi-Cal audit experience via EMRs or hard copy charts.
• Familiar with electronic medical records systems such as Avatar and EPIC, and the Microsoft Office platform.
• Good analytical and organizational skills.
• Ability to perform extensive charting and documentation.

Sitting at the intersection of clinical informatics and research operations, the Clinical Data Specialist leads the translation of end-user data requests into structured analytic datasets, overseeing data cleansing, validation, and governance activities across relational healthcare databases. Operating across research teams composed of informaticists, technologists, and grant-funded investigators, this specialist delivers data standardization frameworks and subject-matter expertise that shape the integrity and usability of health system research outputs.

Duties

• Translate end-user data requests into technical specifications and specific data elements required for data set, report, or data mart development.
• Elicit requirements for new reporting and data requests by interacting with end users.
• Write SQL queries to profile data sources and extract data to fulfill data requests.
• Test and validate the content of reports and data extracts, ensuring customer satisfaction with data provided.
• Create and maintain value sets needed for various research use cases.
• Oversee all activities related to data cleansing, data quality, and data validation using industry standards, creating rules and processes for data quality, validity, and integrity.
• Serve as a healthcare data subject matter expert, providing researchers with advice on research data analysis and effective presentation of results.
• Identify, develop, and document data standardization, data enrichment operations, data validation, data security requirements, and data exception-handling processes.
• Participate in data management, governance, and stewardship activities, including documenting data definitions and data lineage, and prioritizing data enhancement requests.
• Assist with the development of grant proposals, manuscripts, presentations, and training materials with data analyses and data management expertise.
• Train staff with varying degrees of knowledge to effectively use databases and query tools.

Skills & Qualifications

• Bachelor's degree in computer science, statistics, informatics, public health, epidemiology, or a related discipline, with an advanced degree preferred.
• Minimum 5 years of experience working with electronic health record and/or healthcare claims data, with experience in Epic's Clarity and Caboodle databases strongly preferred.
• Prior experience working with healthcare terminologies and code sets such as ICD-10, RxNorm, LOINC, and CPT, and building or using value sets for specific reporting use cases.
• Prior experience working in a research environment and/or knowledge of research Common Data Models such as OMOP, i2b2, PCORnet, and ACT, with OMOP experience a plus.
• Prior experience creating, structuring, cleansing, and validating data sets suitable for statistical analysis.
• Prior experience querying databases with at least basic to intermediate SQL scripting, with the ability to learn various SQL dialects.
• Team player with experience leading and collaborating cross-functionally to ensure successful delivery of solutions.
• Fast learner with the ability to work both independently and in a team environment.

A key member of the clinical data operations team, the Clinical Data Specialist delivers primary review, database entry, and source document verification of submitted clinical trial data in accordance with established SOPs and federal requirements. Collaborating across clinical teams and CRAs, this specialist builds and maintains efficient data management systems, generates quality analytics reports, and ensures that study information and archives meet the accuracy standards required for protocol compliance.

Functions

• Perform primary review of submitted clinical data, entry into databases, and source document verification according to established standard operating procedures.
• Participate in review and verification of data for quality control processes.
• Organize clinical documents according to SOPs and federal requirements.
• Ensure quality in documentation and archiving of clinical data.
• Perform central data monitoring and create data queries.
• Communicate to the clinical team and CRAs important findings that require clinical site notification.
• Assist in the development and implementation of efficient data management systems to accomplish protocol objectives.
• Generate reports and participate in data analysis and data quality analytics.
• Maintain study information, systems, and tools for clinical trials.

Requirements

• Bachelor's degree preferable in the biological or health sciences.
• 1-2 years of experience in clinical research, data management, and/or a clinical setting preferred.
• Database experience preferred.
• Proficient in Microsoft Excel, Word, PowerPoint, and PDF software.
• Professional communication skills with solid oral and written English.
• Attention to detail and excellent organizational skills.
• Discretion in handling confidential information.
• Ability to handle assigned projects and effectively follow written and verbal instructions.
• Ability to contribute to a positive team environment.

Sales force readiness in biotech and medical device organizations depends on the Clinical Data Specialist, who develops and delivers the clinical content that qualifies training presenters on anatomy, physiology, and surgical applications. Serving as the clinical subject matter expert for Instructional Designers and Education Managers, this specialist ensures that training programs reflect current procedural knowledge and are evaluated against measurable learning outcomes.

Accountabilities

• Develop and deliver clinical presentations and activities during sales training programs.
• Train and qualify Sales Training presenters on clinical presentations.
• Work with Education Managers to develop new learning content and evaluations, and improve upon existing training activities.
• Act as a clinical subject matter expert for Instructional Designers.
• Support current procedure advancement alongside engineering and marketing teams.

Experience & Qualifications

• Clinical or Health Science degree preferred, with a Marketing degree acceptable and a college degree required.
• 1-3 years of experience in a biotech or medical device organization preferred.
• Experience with adult learning and education.
• Knowledge of anatomy, physiology, medical disease states, and surgical applications.
• Proficiency with MS Office applications including Word, PowerPoint, and Excel.
• Excellent oral and written communication skills.
• Experienced multi-tasker with the ability to manage multiple projects and meet deadlines.

As the Clinical Data Specialist, this role coordinates and implements performance analysis and reporting in support of Quality Improvement Initiatives, serving Senior Leadership, Clinicians, and Administrators under the direction of the Director of Quality. The Quality Improvement team relies on this work to interface data from external payer and CMS partners, maintain dashboard integrity, and deliver trend reports that underpin contractual and incentive program compliance.

Job Functions

• Implement data collection and reporting strategies for evaluation of key quality performance initiatives, quality metrics, and outcomes evaluation.
• Interface data from external facilities and organizations for reporting purposes, developing and analyzing systems and support tools needed to obtain information or statistics vital to Quality Improvement efforts.
• Investigate data quality problems and reporting issues with recommended solutions.
• Deliver reports and own various Quality metrics dashboards and scoreboards.
• Provide EMR data manually and electronically in support of contractual and incentive programs.
• Collaborate with clinical and IT staff to support defined business requirements.
• Work with external Business Partners such as Payers, ACO, and CMS to facilitate receipt and delivery of quality data.
• Analyze data and prepare data trend reports.
• Maintain consistency and integrity of data collection and storage.

Professional Experience

• Bachelor's Degree in Basic Sciences or a related field, or equivalent work experience.
• Minimum 5 years of progressively responsible related work experience, including knowledge of research methods, basic statistics, business intelligence applications, and data analysis.
• Clinical or healthcare experience preferred.
• Familiarity with EMR and Billing/Claims systems preferred.
• Proficiency with Microsoft Office suite including strong Excel skills.
• Exceptional computer skills with specific strength in reporting metrics.
• Excellent analytical abilities and strong problem-solving skills.
• Strong verbal and written communication skills.
• Detail oriented with excellent follow-up and ability to multi-task in a fast-paced environment.
• Service-oriented, quick learner, and team player.

Clinical Data Specialist shapes data quality outcomes for medical-surgical device and supply catalog engagements, managing database standards and transactional data elements to drive accuracy, consistency, and completeness across a healthcare customer base. The work directly supports provider and supplier customers, internal subject matter experts, and Content Operations teams, requiring a combination of clinical domain knowledge and structured database management to resolve data issues and uphold catalog integrity.

Day-to-Day Responsibilities

• Manage and maintain the database based on defined standards relative to Medical-Surgical devices and supplies to ensure data quality for the customer base.
• Validate and maintain transactional data elements.
• Work in conjunction with other team members as well as provider or supplier customers to ensure timely delivery of accurate data.
• Perform ad hoc queries on multiple large data sets to identify data issues and initiate corrective action.
• Contribute to the development of standards, processes, and procedures that support Content Operations goals and objectives.
• Coordinate and facilitate professional relationships with internal and external subject matter experts to serve as provider/supplier advocate in relation to medical product data quality.

Background & Experience

• Relatable clinical healthcare experience preferred, such as Registered Nurse, Surgical Technician, Respiratory Therapist, or EMT/Paramedic.
• Medical product and terminology knowledge.
• Supply chain knowledge preferred.
• High degree of proficiency in MS Excel required.
• SQL and/or MS Access experience preferred.
• Project management skills a plus.
• Strong customer service and communication skills.