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Clinical Data Managers

SOC 15-2051.02Job Zone 4 · Considerable Preparationv.26.05

Context coveredThis framework covers clinical data management practice across the full lifecycle of regulated clinical trials — from initial database setup and data entry through query resolution, database lock, and regulatory submission — within pharmaceutical, biotech, CRO, and academic research environments.

Sources:O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.SkillsCrosswalkSkillsCrosswalk — O*NET enrichment + adjacency index. Opens in new tab.
Emerging
Entry / Apprentice
  1. Clinical database entry tasks — execute under direct supervision following established data entry protocols in a regulated clinical trial environment.
  2. Standard data receipt and filing procedures — apply consistently using approved electronic data capture systems on assigned study records.
  3. Basic logic check results — recognize and flag discrepancies for senior review during routine data verification activities.
  4. Pre-built data query templates — utilize to document and submit identified data omissions to the clinical data team.
  5. Standard operating procedures for data management — follow precisely to ensure compliance during initial project assignments.
  6. Existing data collection forms — interpret and populate accurately using study-specific instructions provided by senior staff.
  7. Spreadsheet and office suite software — operate to prepare basic data activity listings under guidance from a supervising data manager.
  8. Medical terminology and coding conventions — recognize and apply at a foundational level when processing clinical trial data.
  9. Data formatting specifications — implement as directed when preparing assigned data sets for downstream analytical use.
  10. Progress tracking reports — compile from provided templates to summarize routine data receipt and entry activities for team review.
Developing
Mid-level / Established
  1. Clinical database structures — design and configure with reduced oversight using validated database user interface and query software for mid-sized trial protocols.
  2. Data validation logic checks — develop and test independently to identify entry errors across assigned study databases in a GCP-compliant environment.
  3. Data queries — generate and manage in response to validation failures, resolving discrepancies by coordinating directly with clinical site staff.
  4. Project-specific data management plans — draft covering coding conventions, data transfer schedules, and database lock procedures for single-protocol studies.
  5. Routine data quality metrics — monitor and report to detect deviations from standard operating procedures across ongoing data management activities.
  6. Custom data collection forms — design and refine to support efficient receipt, processing, and tracking of clinical data across assigned trials.
  7. Analytical and categorization software — apply to prepare formatted data sets meeting sponsor or regulatory formatting requirements with minimal direction.
  8. Database lock workflows — coordinate within a study team to ensure timely completion of data cleaning and readiness for statistical analysis.
  9. Performance and progress reports — prepare independently by querying databases and summarizing data entry productivity metrics for project managers.
  10. Time management and task prioritization — exercise routinely to balance simultaneous data management responsibilities across multiple active study protocols.
Proficient
Senior / Expert IC
  1. Complex clinical database architecture — design, validate, and optimize autonomously including advanced logic checks and edit specifications for large multi-site trials.
  2. End-to-end data management plans — author and implement covering full lifecycle from data receipt through database lock, transfer, and regulatory submission.
  3. Non-routine data discrepancies — resolve independently by applying deductive and inductive reasoning to assess root cause and coordinate corrective actions across clinical and statistical teams.
  4. Cross-functional data workflows — evaluate and re-engineer using systems analysis techniques to improve efficiency and compliance in a clinical operations environment.
  5. Programming scripts and queries — develop using object-oriented or scripting tools to automate validation, cleaning, and data transformation processes.
  6. Regulatory and sponsor data standards — interpret and apply across all study deliverables, ensuring data sets conform to CDISC or equivalent frameworks.
  7. Risk-based data monitoring plans — construct and execute to proactively identify data integrity issues before database lock across complex trial portfolios.
  8. Advanced analytical listings and outputs — produce independently to support interim analyses, safety reviews, and final study reports for regulatory submissions.
  9. Vendor and CRO data management activities — oversee and quality-assure to ensure external data pipelines meet contractual and protocol-defined standards.
  10. Mentoring and technical guidance — provide to junior data managers on database design, query resolution, and SOP compliance within day-to-day project work.
Advanced
Lead / Principal / Executive
  1. Organizational data management strategy — define and lead across an enterprise clinical development portfolio, aligning practices with evolving regulatory and industry standards.
  2. Clinical data management SOPs and governance frameworks — author and maintain at the organizational level to ensure consistent, audit-ready data quality practices.
  3. Enterprise-wide database and technology infrastructure — evaluate, select, and champion including EDC platforms, analytical software, and data integration systems.
  4. Departmental competency and talent development programs — design and implement to build clinical data management capability across emerging, developing, and proficient staff.
  5. Executive and regulatory stakeholders — engage and advise on data integrity risks, database lock timelines, and data submission readiness for high-stakes regulatory filings.
  6. Cross-departmental data governance committees — lead to establish enterprise data standards, change control processes, and system validation policies.
  7. Complex problem escalations — resolve at the organizational level by applying systems evaluation and judgment to determine precedent-setting data management decisions.
  8. Innovation and continuous improvement initiatives — drive by evaluating emerging technologies such as risk-based monitoring tools and AI-assisted data cleaning platforms.
  9. Strategic partnerships with CROs, sponsors, and health authorities — negotiate and manage to align data management deliverables with organizational and regulatory objectives.
  10. Organizational performance metrics and quality dashboards — design and champion to provide leadership visibility into data management productivity, compliance, and risk indicators.

AI-at-Work Competency Framework

Sources:Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab.Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab.WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab.
Subscriber feature

Authoritative source data identified for 998 occupations

How a worker at each mastery level uses, directs, and evaluates AI tools in this occupation. Each statement cites its evidence inline; click a citation chip to verify the source.

Emerging
  1. Basic data query assistance — uses an AI tool to surface candidate validation errors and omissions in clinical datasets, then manually reviews each flagged record before submitting a formal query Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  2. Logic check scaffolding — applies AI-generated suggestions for range and consistency checks when designing a new clinical database, verifying each rule against the protocol before implementation Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
Developing
  1. Data validation workflow acceleration — delegates routine receipt, entry, and verification tasks to an AI assistant, reducing processing time while retaining sign-off authority over every record Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  2. Coding and classification support — directs an AI tool to propose MedDRA or WHO-DD coding assignments for adverse events and medications, then audits mappings against codelist standards before locking Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  3. Query generation drafting — tasks an AI assistant with generating data-clarification query text from validation outputs, then edits for protocol-specific language and regulatory compliance.
Proficient
  1. Database design co-authorship — collaborates with an AI assistant throughout the full lifecycle of clinical database design, from schema drafting to UAT script generation, while owning all structural and regulatory decisions Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
  2. Data management plan development — directs an AI tool to produce first-draft sections of project-specific data management plans covering coding conventions, transfer specifications, and database lock procedures, then revises for scientific and regulatory accuracy Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab..
  3. Compliance monitoring automation — configures AI-driven monitoring routines to flag deviations from standard operating procedures in real time, interpreting outputs to prioritize remediation actions WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  4. Critical evaluation of AI outputs — systematically assesses AI-generated validation logic and query recommendations using domain expertise, recognizing that critical thinking tasks remain partially within human territory at this occupation's SAFI score Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
Advanced
  1. End-to-end AI orchestration for data governance — designs and oversees multi-step AI agent workflows that span data receipt through database lock, establishing handoff criteria, audit trails, and override protocols that satisfy regulatory inspection standards Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
  2. AI autonomy boundary-setting — defines scope and risk thresholds for autonomous AI execution across clinical data operations, calibrating delegation levels against trial phase, therapeutic area risk, and regulatory jurisdiction Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab. Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab..
  3. Cross-functional AI integration leadership — directs biostatistics, clinical operations, and IT teams on adopting AI-augmented data management pipelines, translating data quality requirements into machine-readable validation rules and training staff on AI collaboration norms WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab..
Evidence pack
AEI usage
Task observations: 6593
Augment share: 95%
Time saved: 86.8%
AI autonomy: 2.82
SAFI positioning
Top skill: Critical Thinking
Score: 57.9 / 100
precision: category_estimate
WEF cluster
Artificial Intelligence
artificial_intelligence
Sources:Anthropic Economic IndexAnthropic Economic Index — release_2026_03_24. Opens in new tab.Jadhav & Danve, 2026Skill Automation Feasibility Index — Jadhav & Danve, 2026 (arXiv:2604.06906). Opens in new tab.WEF Skills TaxonomyWEF Skills Taxonomy 2021 — Building a Common Language for Skills at Work. Opens in new tab.

Pathsmith Durable Skills Framework

Sources:Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Subscriber feature

Ten durable-skill domains mapped to four proficiency/role levels for each occupation. Each statement is aligned to the Pathsmith taxonomy, derived from trusted grounding data and mapped to occupation-specific O*NET tasks and skills.

1Communication12 statements
Emerging
  1. Data query communication — drafts basic data clarification queries to site coordinators using standard templates to resolve missing or inconsistent clinical trial entries Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Protocol documentation review — reads and summarizes clinical trial protocol sections relevant to data collection requirements for team orientation O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Meeting participation — listens actively during data management team meetings and records action items related to database build timelines Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Data management plan writing — drafts project-specific data management plans covering coding conventions, workflow processes, and database lock procedures for review by senior staff Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Cross-functional query communication — communicates data discrepancies to clinical operations and biostatistics teams using precise, evidence-based language drawn from validation output logs Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Progress reporting — prepares data activity and performance reports summarizing enrollment metrics, query aging, and data entry rates for sponsor review O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory submission communication — compiles and presents data management deliverables, including annotated CRFs and data transfer agreements, in language compliant with ICH E6 and FDA expectations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Stakeholder briefing — leads data reconciliation meetings with clinical sites, CROs, and biostatistics teams, translating complex database validation logic into actionable site guidance Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. SOP authorship — writes and revises standard operating procedures for data receipt, entry, verification, and filing processes with clarity appropriate for cross-departmental audiences O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Executive data reporting — authors high-stakes data integrity summary reports for regulatory agencies and executive sponsors, synthesizing multi-study findings into clear risk narratives Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Communication framework design — establishes study-wide communication templates and escalation protocols for query management that are adopted across the data management department Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Mentored documentation standards — coaches junior data managers on technical writing conventions for data management plans, validation specifications, and CRF completion guidelines Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
2Leadership10 statements
Emerging
  1. Task ownership — takes responsibility for assigned data entry verification tasks within a study team, completing work on schedule without requiring repeated follow-up Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Initiative in error identification — proactively flags recurring data discrepancy patterns to a senior data manager rather than resolving only individual queries in isolation Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Study-level coordination — coordinates data management timelines and task assignments across CRO partners and internal team members for a single clinical trial Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Process improvement initiation — identifies inefficiencies in data cleaning workflows and proposes revised query generation logic or form design changes to team leadership Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Data management lead — serves as lead data manager on complex multi-site trials, directing database build, validation testing, and database lock activities across cross-functional teams Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Compliance oversight — monitors team productivity and data quality metrics against SOPs, addressing performance gaps through direct coaching and process correction O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Vendor oversight — directs CRO data management vendors on study-specific requirements, holding partners accountable to contractual data quality standards and timelines Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Departmental strategy — defines data management operational strategy, resource allocation models, and technology adoption roadmaps across a portfolio of clinical programs Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Organizational standard-setting — chairs data management governance committees, establishing enterprise-wide data quality standards and regulatory readiness benchmarks Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Talent development leadership — mentors and develops a team of data managers at multiple career stages, structuring growth plans aligned to study complexity and regulatory demands Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
3Metacognition8 statements
Emerging
  1. Learning gap recognition — identifies personal knowledge gaps in CDASH or CDISC data standards and seeks targeted training resources before beginning database design tasks Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Task monitoring — tracks personal progress against data entry and query resolution deadlines, adjusting work pace when backlogs emerge Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Validation logic reflection — reviews self-generated edit check specifications after testing to identify patterns of logical error and adjusts specification writing approach accordingly Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory learning integration — actively monitors FDA and EMA guidance updates and evaluates how new expectations affect current data management plan assumptions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Process evaluation — conducts structured post-study retrospectives on data management performance, identifying root causes of query spikes or database lock delays and revising personal workflows Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Cognitive load management — recognizes when simultaneous management of multiple trial databases increases error risk and implements personal prioritization systems to maintain accuracy Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Expert-practice calibration — benchmarks personal data management decision-making against evolving industry standards and regulatory inspection findings, continuously recalibrating methodology Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Metacognitive mentorship — teaches junior data managers structured self-monitoring techniques for database validation and query management tasks, reducing systemic error rates Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
4Critical Thinking9 statements
Emerging
  1. Edit check logic evaluation — examines draft validation check specifications to identify logical inconsistencies or gaps before submitting for programming Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Data error classification — distinguishes between data entry errors, protocol deviations, and systemic collection failures when reviewing flagged discrepancies during cleaning O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Root cause analysis — investigates clusters of data queries across clinical sites to determine whether issues originate from CRF design flaws, site training gaps, or systemic protocol ambiguities Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Risk-based data review — applies critical analysis to data trends and outlier patterns to prioritize targeted data cleaning activities on variables with highest impact on primary endpoints Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Database design critique — evaluates proposed database architectures and data collection instruments against protocol requirements, regulatory standards, and downstream statistical analysis needs Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Assumption testing in data transfers — scrutinizes data transfer specifications and mapping assumptions between EDC systems and statistical analysis environments to prevent downstream analytic errors O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Validation plan assessment — critically evaluates user acceptance testing results, distinguishing critical failures requiring database redesign from acceptable minor deviations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Cross-study evidence synthesis — analyzes data quality patterns across a clinical program portfolio to identify systemic CRF design or site management issues and formulates evidence-based corrective strategies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Regulatory inspection readiness critique — critically assesses data management documentation packages against current regulatory inspection expectations, identifying evidentiary gaps before submission Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
5Collaboration9 statements
Emerging
  1. Interdepartmental coordination — participates constructively in kickoff meetings with clinical operations, biostatistics, and regulatory affairs to align data collection requirements Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Site liaison support — collaborates with clinical site coordinators to clarify CRF completion instructions, resolving ambiguities that generate repeat queries O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Cross-functional database development — collaborates with biostatisticians and programmers to ensure database structures and data dictionaries meet analysis dataset requirements Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. CRO partnership management — works cooperatively with contract research organization data teams to align on data management plan deliverables, timelines, and quality expectations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Integrated study team contribution — functions as the data management expert within a multi-disciplinary study team, ensuring data considerations are incorporated into protocol amendments, SAPs, and regulatory submissions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Conflict resolution in data disputes — navigates disagreements between clinical operations and data management on query resolution decisions by facilitating evidence-based consensus discussions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Collaborative SOP development — co-develops and cross-validates standard operating procedures with quality assurance, IT, and clinical operations stakeholders O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Enterprise collaboration architecture — designs collaborative frameworks connecting data management, regulatory affairs, biometrics, and clinical operations across multi-sponsor or multi-CRO trial structures Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Industry working group participation — represents the organization in cross-industry data standards consortia such as CDISC or TransCelerate, contributing organizational expertise to shared standard development Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
6Character9 statements
Emerging
  1. Data integrity commitment — accurately records and reports data discrepancies without modification, even when corrections would appear to improve site or study performance metrics Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Confidentiality compliance — handles patient-level clinical trial data in accordance with applicable privacy regulations and organizational data security policies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Audit trail accountability — maintains complete and transparent documentation of all database modifications, query resolutions, and deviation decisions in the electronic data capture system Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Ethical query management — generates data queries based solely on validation logic and protocol requirements, avoiding pressure from sponsors or sites to selectively clean data Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Regulatory integrity — upholds 21 CFR Part 11 and ICH E6 data integrity standards under sponsor and timeline pressure, escalating compliance concerns through appropriate channels Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Professional accountability — accepts responsibility for database design or validation errors, conducts thorough impact assessments, and implements documented corrective actions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Conflict-of-interest navigation — maintains objectivity in data cleaning decisions when organizational or sponsor interests conflict with unbiased data representation Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Integrity culture leadership — establishes a departmental culture of data integrity by modeling transparent error reporting, championing audit readiness, and institutionalizing zero-tolerance policies for data manipulation Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Ethics advisory contribution — advises organizational leadership and IRBs on data governance ethical considerations arising from novel data collection technologies or adaptive trial designs Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
7Creativity9 statements
Emerging
  1. Form design innovation — proposes user-friendly CRF layout modifications that reduce site data entry burden while maintaining protocol-required data capture Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Query template improvement — suggests revised query wording that reduces site misinterpretation and lowers re-query rates on common data fields O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Developing
  1. Validation logic design — develops novel edit check logic to detect complex protocol deviation patterns not addressed by standard validation libraries Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Workflow innovation — designs creative data management workflow solutions that reduce database lock timelines without compromising data quality standards Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Risk-based monitoring design — creates innovative risk-based data review frameworks that combine centralized statistical monitoring with targeted source data verification for specific data signals Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Technology integration — identifies and pilots emerging EDC or data integration technologies that improve data collection efficiency or real-time data quality visibility for the organization Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Adaptive data management planning — designs flexible data management plans that accommodate protocol amendments mid-study without requiring full database rebuilds Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Exceeding
  1. Industry methodology innovation — develops and publishes novel data management methodologies, such as machine learning-assisted query generation or automated data reconciliation approaches, advancing field practice Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Organizational transformation design — architects creative organizational data management models, including decentralized clinical trial data strategies, that reposition the department's competitive capability Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
8Growth Mindset9 statements
Emerging
  1. Regulatory standard learning — engages with updated CDISC CDASH and SDTM standards proactively, applying new conventions to ongoing database design tasks even when relearning is required Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Feedback integration — incorporates supervisor feedback on query generation logic or data management plan structure into subsequent deliverables without defensiveness Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Technology adoption — embraces unfamiliar EDC platforms or data integration tools assigned to new studies, investing personal effort to build proficiency before go-live milestones Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Audit finding response — treats inspection observations and internal audit findings as learning opportunities, implementing corrective actions and sharing lessons learned with the team Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Complexity escalation — actively pursues assignment to increasingly complex therapeutic area databases and adaptive trial designs to expand technical competency Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Continuous process improvement — systematically analyzes post-study performance data to identify personal and team skill gaps, building targeted development plans for subsequent studies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Cross-domain learning — acquires working knowledge of biostatistics, pharmacovigilance, and regulatory affairs to improve integration of data management outputs with downstream functions Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Learning culture creation — institutionalizes continuous learning within the data management function by establishing communities of practice, internal knowledge-sharing forums, and structured lessons-learned processes Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Field-level growth advocacy — contributes to industry training programs and conference presentations, sharing organizational learning to elevate data management competency standards across the field Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
9Mindfulness9 statements
Emerging
  1. Attention management during data entry — applies focused attention strategies during high-volume data entry verification tasks to maintain accuracy and detect subtle discrepancies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Deadline awareness — monitors personal workload relative to database lock and submission timelines, recognizing early warning signs of cognitive overload before errors accumulate Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Intentional query review — pauses to systematically review validation output before generating queries, avoiding reactive or incomplete responses to error flags under study deadline pressure Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Stress regulation during audits — maintains composed, methodical responses during regulatory inspections or sponsor audits, accessing accurate documentation without reactive or imprecise communication Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Applying
  1. Present-focused database validation — conducts user acceptance testing with deliberate, structured attention to each test case, preventing confirmation bias from influencing pass/fail determinations Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Emotional regulation in conflict — manages interpersonal tension with clinical sites or sponsors during contentious query resolution discussions with measured, data-grounded responses Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  3. Intentional prioritization — applies mindful triage to competing study deliverables across a multi-trial portfolio, making deliberate sequencing decisions based on regulatory impact and risk Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Mindful leadership modeling — demonstrates and teaches intentional attention management practices to data management teams operating under sustained regulatory and timeline pressure Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Organizational stress resilience — designs team workflow structures and meeting cadences that reduce reactive decision-making and promote deliberate, quality-focused data management practice across the department Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
10Fortitude9 statements
Emerging
  1. Deadline persistence — sustains focused effort on data cleaning tasks through end-of-study database lock periods even when query volumes are high and timelines are compressed Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Error recovery — responds to discovery of personal data entry or validation errors by methodically assessing impact and implementing corrections without disengagement or avoidance Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Developing
  1. Regulatory pressure endurance — maintains data quality standards and complete audit trail documentation during pre-submission periods when sponsor pressure to accelerate database lock intensifies Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  2. Ambiguity tolerance — proceeds with database design and validation planning when protocol details are incomplete or evolving, making documented provisional decisions while pursuing clarification Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Applying
  1. Multi-study resilience — sustains consistent data management performance across simultaneous management of multiple high-complexity trials with competing lock and submission deadlines Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Inspection readiness under adversity — prepares comprehensive regulatory inspection-ready documentation packages under compressed timelines following sponsor audit notifications Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
  3. Post-rejection persistence — revises rejected data management deliverables following sponsor or regulatory feedback with sustained analytical effort and without abandoning quality standards Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
Exceeding
  1. Organizational crisis leadership — leads the data management function through major regulatory hold, data integrity breach, or system failure events, maintaining team cohesion and recovery momentum Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.
  2. Long-cycle program endurance — sustains strategic oversight and quality governance across multi-year clinical development programs through repeated protocol amendments, regulatory setbacks, and organizational changes Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab. O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Sources:Pathsmith Durable SkillsPathsmith Durable Skills Framework — America Succeeds + CompTIA. Opens in new tab.O*NET v30.2O*NET Resource Center — Occupational Information Network, v30.2 (Sept 2025). Opens in new tab.
Show O*NET source anchors57 anchors · skillscrosswalk.com

O*NET enrichment · skillscrosswalk.com

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Source anchors that ground each statement

Related titles
Abstractor · Analyst · Application Analyst · Application Coordinator · Clinical Applications Director · Clinical Biostatistics Director · Clinical Data Abstractor · Clinical Data Analyst · Clinical Data Coordinator · Clinical Data Management Director (CDM Director) · Clinical Data Management Manager (CDM Manager) · Clinical Data Manager
RAPIDS apprenticeships
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O*NET skills
Critical ThinkingSpeakingReading ComprehensionActive ListeningWritingActive LearningMonitoringMathematicsComplex Problem SolvingCoordinationTime ManagementSystems AnalysisProgrammingJudgment and Decision MakingSocial PerceptivenessSystems EvaluationManagement of Personnel ResourcesInstructing
Knowledge domains
English LanguageComputers and ElectronicsCustomer and Personal ServiceMathematicsMedicine and Dentistry
Abilities
Deductive ReasoningInformation OrderingOral ExpressionWritten ComprehensionOral ComprehensionNear VisionProblem SensitivityInductive ReasoningWritten ExpressionSpeech Recognition
Work styles
Attention to DetailDependabilityIntegrityCautiousnessIntellectual CuriosityAchievement Orientation
Technology
Data base user interface and query softwareMedical softwareCategorization or classification softwareObject or component oriented development softwareAccess softwareAnalytical or scientific softwareEnterprise application integration softwareDevelopment environment softwareSpreadsheet softwareOffice suite software
Tasks · seed anchors for statements
  1. Design and validate clinical databases, including designing or testing logic checks.
  2. Process clinical data, including receipt, entry, verification, or filing of information.
  3. Generate data queries, based on validation checks or errors and omissions identified during data entry, to resolve identified problems.
  4. Develop project-specific data management plans that address areas such as coding, reporting, or transfer of data, database locks, and work flow processes.
  5. Monitor work productivity or quality to ensure compliance with standard operating procedures.
  6. Prepare appropriate formatting to data sets as requested.
  7. Design forms for receiving, processing, or tracking data.
  8. Prepare data analysis listings and activity, performance, or progress reports.
CIP education codes
11.010211.010311.070111.080211.080426.110326.110426.119927.010127.030127.030327.030427.030527.030627.039927.050127.050227.050327.060127.999930.080130.300130.390130.480130.700130.709930.710130.710230.710330.710430.719940.051245.060352.130152.1302

Sources: O*NET v30.2 (CC BY 4.0), SkillsCrosswalk.com, LER.me, Anthropic Economic Index, SAFI (Jadhav & Danve, 2026), WEF Skills Taxonomy 2021, Pathsmith Durable Skills Framework. © 2026 EBSCOed.