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Clinical Data Standards Jobs (NOW HIRING)

ICON

Clinical Data Standard Consultant

Blue Bell, PA · On-site +1

A Principal Clinical Data Standards Consultant is responsible for supporting the operational staff in the use of ADaM and the define.xml capture for statistical analysis within the Medidata standard.

Faeth Therapeutics

Clinical Data Manager

Austin, TX · On-site

$125K - $175K/yr

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M ... Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure ...

Faeth Therapeutics

Clinical Data Manager

Austin, TX · Remote

$125K - $175K/yr

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M ... Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure ...

Faeth Therapeutics

Clinical Data Manager

Austin, TX · Remote

$125K - $175K/yr

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M ... Collaborate with biostatistics on data standards (e.g., CDISC/SDTM) and analysis datasets * Ensure ...

IQVIA

Mgr, Database Management Systems

Boston, MA

Essential Functions Clinical Data Standards & Operational Mapping * Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g ...

IQVIA

Mgr, Database Management Systems

Hartford, CT · On-site

Essential Functions Clinical Data Standards & Operational Mapping * Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g ...

IQVIA

Mgr, Database Management Systems

Newark, NJ · On-site

Essential Functions Clinical Data Standards & Operational Mapping * Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g ...

IQVIA

Mgr, Database Management Systems

Miami, FL

Essential Functions Clinical Data Standards & Operational Mapping * Participate in the development and maintenance of global clinical data standards, including operational (eCRF and non-eCRF (e.g ...

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Clinical Data Standards information

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How much do clinical data standards jobs pay per hour?

As of Jul 23, 2026, the average hourly pay for clinical data standards in the United States is $38.95, according to ZipRecruiter salary data. Most workers in this role earn between $29.33 and $38.94 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Clinical Data Standards position, and why are they important?

To thrive in Clinical Data Standards, you need a comprehensive understanding of clinical data management, regulatory requirements, and standards such as CDISC, supported by a relevant degree in life sciences, informatics, or a related field. Expertise with data standards tools (e.g., SAS, Pinnacle 21, Medidata Rave) and certifications like CDISC or SAS are often necessary. Strong attention to detail, analytical thinking, and effective communication skills distinguish top performers in this role. These competencies ensure the accurate and compliant structure of clinical trial data, facilitating smooth regulatory submissions and effective collaboration across multidisciplinary teams.

What is a Clinical Data Standards job?

A Clinical Data Standards job involves developing, implementing, and maintaining standardized data structures, formats, and terminologies to ensure consistency, accuracy, and regulatory compliance in clinical research. Professionals in this role work with CDISC standards (such as SDTM and ADaM), metadata management, and regulatory submission requirements. They collaborate with cross-functional teams, including data management, biostatistics, and regulatory affairs, to optimize data collection, analysis, and reporting. This role is essential for improving data quality, reducing redundancies, and ensuring seamless data integration across studies.

What are some typical challenges faced by professionals working in Clinical Data Standards roles?

Professionals in Clinical Data Standards frequently encounter challenges such as keeping up with evolving industry standards, ensuring data consistency across complex global studies, and coordinating input from various stakeholders including clinical, regulatory, and IT teams. Managing data standardization for legacy datasets and adapting processes to meet the unique requirements of each clinical trial can also be demanding. However, these challenges offer excellent opportunities for continuous learning and skill development, making the role both dynamic and rewarding for those who enjoy problem-solving. Most roles offer a collaborative environment where teamwork and cross-functional communication are essential to success.

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Clinical Data Standards jobs near you
Infographic showing various Clinical Data Standards job openings in the United States as of July 2026, with employment types broken down into 2% As Needed, 73% Full Time, 17% Part Time, and 8% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $81,020 per year, or $39 per hour.
Clinical Data Management SME with Data Architectecture or Data Engineering Experience

Clinical Data Management SME with Data Architectecture or Data Engineering Experience

V.L.S. Systems, Inc

Alameda, CA • On-site

Other

Posted 27 days ago

Job description

Data Architect or Senior Data Engineer with experience in Clinical SDTM Data Management***

The SME should have strong experience working in clinical IT environments with a strong business-facing orientation, closely partnering with stakeholders across Biostatistics, Statistical Programming, Clinical Operations, and Clinical Data Management.

This role requires deep hands-on expertise in clinical data standards and regulatory submission datasets, with frequent collaboration with Biostatistics teams to ensure high-quality downstream analysis-ready data.

Key Responsibilities & Collaboration Areas

Work closely with Biostatistics teams to support study design, analysis readiness, and submission data strategy

Partner with Statistical Programmers to ensure correct implementation of analysis datasets

Collaborate with Clinical Data Managers (CDM) to ensure source data aligns with downstream SDTM requirements

Interface with Clinical Operations (Clin Ops) to ensure operational data capture supports analysis needs

Act as a bridge between IT systems/data architecture and clinical study execution teams

Core Technical Expertise Required

Strong expertise in CDISC standards, especially:

CDISC Standards

Deep knowledge of SDTM (Study Data Tabulation Model) including:

Domain structures and mapping from raw clinical data

Controlled terminology and implementation guidelines

Submission-ready SDTM datasets

Strong understanding of ADaM (Analysis Data Model):

Dataset creation for statistical analysis

Traceability from SDTM ? ADaM ? TLFs (Tables, Listings, Figures)

Experience with SDTM domain mapping specifications and transformation logic

Familiarity with regulatory submission expectations (e.g., FDA/PMDA)

Ideal Profile

Proven experience working in clinical trial data environments

Hands-on exposure to SDTM and ADaM dataset creation or review

Strong ability to translate between:

Clinical/business requirements

Statistical analysis needs

Technical data structures

Comfortable engaging in deep technical discussions with biostatisticians

Ability to act as a translation layer between IT/data systems and scientific teams

We are seeking a Senior Clinical Data Management SME to provide clinical data leadership across active studies. This role will own clinical data standards, study-level data management planning, data quality planning, SDTM/ADaM mapping oversight, CRO/vendor data onboarding, and translation of clinical study requirements into data pipeline specifications.

The role requires deep experience in clinical data management, CDISC standards, SDTM/ADaM, eCRF design, study protocols, data quality, vendor governance, and clinical data delivery.

________________________________________

Key Responsibilities

Serve as the primary Clinical Data Management SME across active clinical studies.

Own and maintain CDISC standards, Clinical Data Management Plans, and Data Quality Plans.

Own SDTM/ADaM mapping authority across studies and validate domain conformance.

Review and approve SDTM/ADaM mappings, data quality rules, and study artifacts before release to production.

Govern CRO and vendor data onboarding, including data transfer plans, SLAs, acceptance criteria, in-stream data flows, and exception handling.

Translate study protocols, eCRFs, and reporting/analysis plans into pipeline requirements for data engineering teams.

Partner with Clinical Operations, Biostatistics, Data Management, CROs, data engineers, and data managers.

Ensure study data is complete, accurate, traceable, standardized, and ready for downstream analysis.

Provide SME guidance to offshore engineers and data managers on clinical data standards, mappings, and study-specific requirements.

Support issue resolution related to clinical data quality, mapping gaps, transformation logic, and vendor data defects.

________________________________________

Required Qualifications

10+ years of experience in Clinical Data Management within pharma, biotech, or CRO environments.

Strong working knowledge of CDISC, SDTM, and ADaM standards.

Experience with:

o Clinical Data Management Plans

o Data Quality Plans

o Data Transfer Plans

o eCRF specifications

o SDTM/ADaM mapping specifications

o Edit checks and validation rules

o Clinical data review and reconciliation

Ability to interpret study protocols, eCRFs, CRF annotations, reporting plans, and analysis plans.

Experience managing or coordinating with CROs and third-party data vendors.

Strong understanding of clinical trial data lifecycle from data collection through analysis and submission readiness.

Ability to convert clinical requirements into clear technical specifications.

Strong communication and stakeholder management skills.

________________________________________

Preferred Qualifications

Experience with regulatory submission data packages.

Experience with EDC systems, clinical data repositories, clinical data hubs, or clinical data platforms.

Familiarity with metadata-driven pipelines, automation, or AI-assisted data mapping and rule generation.

Experience supporting oncology or specialty pharma studies.

Experience working with distributed onsite/offshore delivery teams.

Knowledge of data governance, lineage, auditability, and quality controls in clinical data environments.

________________________________________

Key Skills

Clinical Data Management, CDISC, SDTM, ADaM, eCRF, Study Protocols, Data Quality, Data Transfer Plans, CRO/Vendor Governance, Data Mapping, Clinical Data Standards, Edit Checks, Data Reconciliation, Regulatory Submission Readiness, Clinical Operations, Biostatistics, Data Engineering Collaboration.

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