Director Data Management
for section headings (e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to map content accordingly.
We must not repeat job title as heading. No Job ID. Remove boilerplate (equal opportunity etc). Keep all substantive info.
We need sections only when posting has real specific content. So we can have sections: About the role (maybe "About the role" corresponds to description of role). Responsibilities (What You’ll Do). Requirements/Qualifications (What You’ll Bring). Benefits (What We Offer You). Possibly Skills? Could combine.
We need to use - for any list of duties/requirements/benefits, and
for prose.
We need to preserve all substantive info, not invent or summarize away detail. So we need to keep details like specific tasks, technologies, etc.
We need to output only HTML fragment, no /, no markdown fences.
Let's parse content:
Intro about Pedestal Health: "About Pedestal Health Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com."
That's about the company, not role. Could be placed under a section "About the company"? But headings list includes "About the role". Not "About the company". However we could still use "About the role" for role description. The intro about company could be placed as a
before any heading? The instruction: "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid other headings, but suggests using those. Probably we should include a section for company overview maybe as a
without heading? But they said "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". So we can have a heading "About the role" with content describing the role (The Role). The company intro could be placed before any heading as a
. That seems okay.
Let's structure:
About Pedestal Health ...
About the role
The Director, Data Management leads Pedestal Health's clinical data management (CDM) function across our prospective studies, clinical trials, external control arms, and registry cohorts. This is a hands-on leadership role responsible for the design and build of study databases, the standards that govern data collection, medical coding, and the delivery of analysis-ready, submission-grade datasets. The Director owns data quality, timelines, and regulatory compliance from study startup through database lock, and builds the people, processes, SOPs, and technology that let the function scale.
Then Responsibilities: "What You’ll Do" with bullet points.
We need to convert each bullet into - . The bullet list includes multiple sections: EDC Design & Build, CRF & Data Collection Standards, Medical Coding, SDTM & ADaM / Regulatory Deliverables, Data Quality, Delivery & Compliance, Leadership & Vendor Management. Each has sub-bullets. We could either flatten all into a single list, but better to preserve structure? The instruction: Use
- for any list of duties/requirements/benefits. It doesn't forbid nested lists? Probably okay to have nested
. But to keep simple, we could make each main bullet as - containing the description, and sub-bullets as nested
. That preserves detail.
Let's extract:
EDC Design & Build:
- Lead the design, build, configuration, and validation of Electronic Data Capture (EDC) databases (e.g., Medidata Rave, Veeva Vault CDMS, Oracle Clinical/InForm) across the study portfolio.
- Own database specifications, edit checks, dynamics, derivations, and user-acceptance testing (UAT); ensure builds are validated and audit-ready prior to go-live.
- Manage study startup, mid-study amendments, and database migrations with minimal disruption to sites and ongoing data flow.
- Oversee integration of external and non-CRF data sources (labs, ePRO/eCOA, imaging, biomarkers, EHR-derived data) into the study database.
CRF & Data Collection Standards:
- Author and maintain CRF/eCRF design guidelines, CRF Completion Guidelines, and a library of reusable standard forms aligned to CDISC CDASH.
- Partner with clinical, biostatistics, and medical teams to translate protocols into efficient, high-quality data collection instruments.
- Establish and govern data management standards, conventions, and SOPs to drive consistency and reusability across studies.
Medical Coding:
- Oversee medical coding of adverse events, medical history, and concomitant medications using MedDRA and WHODrug.
- Either lead coding in-house or manage and oversee a coding vendor - defining coding conventions, reviewing auto-encoding and manual review, resolving queries, and ensuring dictionary version control and supervising
- Ensure coding accuracy, consistency, and timeliness, and reconcile coded terms with safety and clinical review.
SDTM & ADaM / Regulatory Deliverables:
- Own the strategy and quality of CDISC-conformant deliverables, ensuring source data map cleanly to SDTM and support downstream ADaM datasets for statistical analysis and submission.
- Direct the creation and review of SDTM datasets, annotated CRFs, define.xml, and the Study Data Reviewer's Guide (SDRG/cSDRG), and coordinate ADaM specifications with biostatistics/programming.
- Run Pinnacle 21 (or equivalent) conformance checks and resolve findings to ensure FDA/EMA submission-readiness.
Data Quality, Delivery & Compliance:
- Own end-to-end data cleaning, query management, discrepancy and SAE reconciliation, and database lock activities - delivering clean, on-time data.
- Define and monitor data quality metrics, dashboards, and KPIs; report status and risks to study teams and leadership.
- Ensure all activities comply with ICH-GCP, 21 CFR Part 11, applicable FDA/EMA regulations, and internal SOPs; support audits and inspections.
Leadership & Vendor Management:
- Build, mentor, and manage a team of clinical data managers, programmers, and coders; set standards, allocate resources, and develop talent.
- Manage CRO and technology vendors - scope, budgets, timelines, oversight, and quality - for outsourced data management and coding.
- Contribute to proposals, timelines, and budgets, and represent data management with sponsors and partners.
- Serve as SME and thought leader both inside and outside the organization.
Now Requirements/Qualifications: "What You’ll Bring"
List:
- Bachelor's degree in life sciences, health informatics, computer science, or a related field (advanced degree a plus).
- 10+ years of clinical data management experience, including 3+ years leading or managing teams, in a pharma, biotech, CRO, or RWE setting.
- Demonstrated, hands-on expertise building and validating EDC databases (Medidata Rave, Veeva, Oracle, or similar).
- Proficiency with CDISC standards - CDASH, SDTM, and ADaM - and submission deliverables (define.xml, annotated CRF, reviewer's guides).
- Experience overseeing medical coding with MedDRA and WHODrug, whether in-house or via a coding vendor.
- Strong working knowledge of ICH-GCP, 21 CFR Part 11, and FDA/EMA regulatory requirements.
- Proven ability to manage CROs and vendors, budgets, and multiple concurrent studies to deadline.
Nice to Have:
- Society for Clinical Data Management (SCDM) certification (CCDM) or equivalent.
- Experience with real-world evidence, registries, external control arms, or EHR-derived data.
- Familiarity with Pinnacle 21, SAS, and/or data-review programming.
- Therapeutic-area experience in hepatology, dermatology, or gastroenterology.
We could separate into Requirements and Nice to Have (maybe Skills). But headings list includes Requirements, Qualifications, Skills. We could put Requirements under Requirements
and Qualifications under Qualifications
but they'd be similar. Perhaps combine into one section "Requirements". But we need to follow instruction: Use heading only when posting has real specific content. We have both required and nice-to-have. Could make two sections: Requirements and Nice to Have (or Skills). The heading list includes Skills, so we could put nice-to-have under Skills.
Thus:
Requirements
with required items.
Skills
with nice-to-have items.
Benefits: "What We Offer You"
List:
- Hybrid work arrangement, with regular onsite collaboration at a Pedestal Health office
- Comprehensive health, dental, and vision coverage
- 401(k) with company match
- Generous PTO and paid parental leave
We need to output as Benefits
...
We should not include Pay or Schedule sections as not present.
We must remove boilerplate: equal opportunity employer etc. Also remove "Learn more at pedestalhealth.com."? That's part of company intro; it's substantive? It's a link but maybe we can keep as plain text. It's not boilerplate; it's a reference. Keep.
We must not include duplicated lines.
Now produce HTML.
Let's craft:
About Pedestal Health Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com.
About the role
The Director, Data Management leads Pedestal Health's clinical data management (CDM) function across our prospective studies, clinical trials, external control arms, and registry cohorts. This is a hands-on leadership role responsible for the design and build of study databases, the standards that govern data collection, medical coding, and the delivery of analysis-ready, submission-grade datasets. The Director owns data quality, timelines, and regulatory compliance from study startup through database lock, and builds the people, processes, SOPs, and technology that let the function scale.
Responsibilities
- EDC Design & Build
- Lead the design, build, configuration, and validation of Electronic Data Capture (EDC) databases (e.g., Medidata Rave, Veeva Vault CDMS, Oracle Clinical/InForm) across the study portfolio.
- Own database specifications, edit checks, dynamics, derivations, and user-acceptance testing (UAT); ensure builds are validated and audit-ready prior to go-live.
- Manage study startup, mid-study amendments, and database migrations with minimal disruption to sites and ongoing data flow.
- Oversee integration of external and non-CRF data sources (labs, ePRO/eCOA, imaging, biomarkers, EHR-derived data) into the study database.
for prose. We need to preserve all substantive info, not invent or summarize away detail. So we need to keep details like specific tasks, technologies, etc. We need to output only HTML fragment, no /, no markdown fences. Let's parse content: Intro about Pedestal Health: "About Pedestal Health Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com." That's about the company, not role. Could be placed under a section "About the company"? But headings list includes "About the role". Not "About the company". However we could still use "About the role" for role description. The intro about company could be placed as a
before any heading? The instruction: "Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It doesn't forbid other headings, but suggests using those. Probably we should include a section for company overview maybe as a
without heading? But they said "include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text". So we can have a heading "About the role" with content describing the role (The Role). The company intro could be placed before any heading as a
. That seems okay. Let's structure:
About Pedestal Health ...
About the role
The Director, Data Management leads Pedestal Health's clinical data management (CDM) function across our prospective studies, clinical trials, external control arms, and registry cohorts. This is a hands-on leadership role responsible for the design and build of study databases, the standards that govern data collection, medical coding, and the delivery of analysis-ready, submission-grade datasets. The Director owns data quality, timelines, and regulatory compliance from study startup through database lock, and builds the people, processes, SOPs, and technology that let the function scale.
Then Responsibilities: "What You’ll Do" with bullet points. We need to convert each bullet into- . The bullet list includes multiple sections: EDC Design & Build, CRF & Data Collection Standards, Medical Coding, SDTM & ADaM / Regulatory Deliverables, Data Quality, Delivery & Compliance, Leadership & Vendor Management. Each has sub-bullets. We could either flatten all into a single list, but better to preserve structure? The instruction: Use
- for any list of duties/requirements/benefits. It doesn't forbid nested lists? Probably okay to have nested
- . But to keep simple, we could make each main bullet as
- containing the description, and sub-bullets as nested
- . That preserves detail.
Let's extract:
EDC Design & Build:
- Lead the design, build, configuration, and validation of Electronic Data Capture (EDC) databases (e.g., Medidata Rave, Veeva Vault CDMS, Oracle Clinical/InForm) across the study portfolio.
- Own database specifications, edit checks, dynamics, derivations, and user-acceptance testing (UAT); ensure builds are validated and audit-ready prior to go-live.
- Manage study startup, mid-study amendments, and database migrations with minimal disruption to sites and ongoing data flow.
- Oversee integration of external and non-CRF data sources (labs, ePRO/eCOA, imaging, biomarkers, EHR-derived data) into the study database.
CRF & Data Collection Standards:
- Author and maintain CRF/eCRF design guidelines, CRF Completion Guidelines, and a library of reusable standard forms aligned to CDISC CDASH.
- Partner with clinical, biostatistics, and medical teams to translate protocols into efficient, high-quality data collection instruments.
- Establish and govern data management standards, conventions, and SOPs to drive consistency and reusability across studies.
Medical Coding:
- Oversee medical coding of adverse events, medical history, and concomitant medications using MedDRA and WHODrug.
- Either lead coding in-house or manage and oversee a coding vendor - defining coding conventions, reviewing auto-encoding and manual review, resolving queries, and ensuring dictionary version control and supervising
- Ensure coding accuracy, consistency, and timeliness, and reconcile coded terms with safety and clinical review.
SDTM & ADaM / Regulatory Deliverables:
- Own the strategy and quality of CDISC-conformant deliverables, ensuring source data map cleanly to SDTM and support downstream ADaM datasets for statistical analysis and submission.
- Direct the creation and review of SDTM datasets, annotated CRFs, define.xml, and the Study Data Reviewer's Guide (SDRG/cSDRG), and coordinate ADaM specifications with biostatistics/programming.
- Run Pinnacle 21 (or equivalent) conformance checks and resolve findings to ensure FDA/EMA submission-readiness.
Data Quality, Delivery & Compliance:
- Own end-to-end data cleaning, query management, discrepancy and SAE reconciliation, and database lock activities - delivering clean, on-time data.
- Define and monitor data quality metrics, dashboards, and KPIs; report status and risks to study teams and leadership.
- Ensure all activities comply with ICH-GCP, 21 CFR Part 11, applicable FDA/EMA regulations, and internal SOPs; support audits and inspections.
Leadership & Vendor Management:
- Build, mentor, and manage a team of clinical data managers, programmers, and coders; set standards, allocate resources, and develop talent.
- Manage CRO and technology vendors - scope, budgets, timelines, oversight, and quality - for outsourced data management and coding.
- Contribute to proposals, timelines, and budgets, and represent data management with sponsors and partners.
- Serve as SME and thought leader both inside and outside the organization.
Now Requirements/Qualifications: "What You’ll Bring"
List:
- Bachelor's degree in life sciences, health informatics, computer science, or a related field (advanced degree a plus).
- 10+ years of clinical data management experience, including 3+ years leading or managing teams, in a pharma, biotech, CRO, or RWE setting.
- Demonstrated, hands-on expertise building and validating EDC databases (Medidata Rave, Veeva, Oracle, or similar).
- Proficiency with CDISC standards - CDASH, SDTM, and ADaM - and submission deliverables (define.xml, annotated CRF, reviewer's guides).
- Experience overseeing medical coding with MedDRA and WHODrug, whether in-house or via a coding vendor.
- Strong working knowledge of ICH-GCP, 21 CFR Part 11, and FDA/EMA regulatory requirements.
- Proven ability to manage CROs and vendors, budgets, and multiple concurrent studies to deadline.
Nice to Have:
- Society for Clinical Data Management (SCDM) certification (CCDM) or equivalent.
- Experience with real-world evidence, registries, external control arms, or EHR-derived data.
- Familiarity with Pinnacle 21, SAS, and/or data-review programming.
- Therapeutic-area experience in hepatology, dermatology, or gastroenterology.
We could separate into Requirements and Nice to Have (maybe Skills). But headings list includes Requirements, Qualifications, Skills. We could put Requirements under
- EDC Design & Build
- Lead the design, build, configuration, and validation of Electronic Data Capture (EDC) databases (e.g., Medidata Rave, Veeva Vault CDMS, Oracle Clinical/InForm) across the study portfolio.
- Own database specifications, edit checks, dynamics, derivations, and user-acceptance testing (UAT); ensure builds are validated and audit-ready prior to go-live.
- Manage study startup, mid-study amendments, and database migrations with minimal disruption to sites and ongoing data flow.
- Oversee integration of external and non-CRF data sources (labs, ePRO/eCOA, imaging, biomarkers, EHR-derived data) into the study database.
Requirements
and Qualifications underQualifications
but they'd be similar. Perhaps combine into one section "Requirements". But we need to follow instruction: Use heading only when posting has real specific content. We have both required and nice-to-have. Could make two sections: Requirements and Nice to Have (or Skills). The heading list includes Skills, so we could put nice-to-have under Skills. Thus:Requirements
- with required items.
Skills
- with nice-to-have items.
Benefits: "What We Offer You"
List:
- Hybrid work arrangement, with regular onsite collaboration at a Pedestal Health office
- Comprehensive health, dental, and vision coverage
- 401(k) with company match
- Generous PTO and paid parental leave
We need to output as
Benefits
- ...
We should not include Pay or Schedule sections as not present.
We must remove boilerplate: equal opportunity employer etc. Also remove "Learn more at pedestalhealth.com."? That's part of company intro; it's substantive? It's a link but maybe we can keep as plain text. It's not boilerplate; it's a reference. Keep.
We must not include duplicated lines.
Now produce HTML.
Let's craft:
About Pedestal Health Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com.
About the role
The Director, Data Management leads Pedestal Health's clinical data management (CDM) function across our prospective studies, clinical trials, external control arms, and registry cohorts. This is a hands-on leadership role responsible for the design and build of study databases, the standards that govern data collection, medical coding, and the delivery of analysis-ready, submission-grade datasets. The Director owns data quality, timelines, and regulatory compliance from study startup through database lock, and builds the people, processes, SOPs, and technology that let the function scale.
Responsibilities
- EDC Design & Build
- containing the description, and sub-bullets as nested
- for any list of duties/requirements/benefits. It doesn't forbid nested lists? Probably okay to have nested