Senior Manager, Clinical Data Ingestion
Takeda
6 hours ago
Remote
United States
$137,000 - $215,270 USD yearly
Operations
OBJECTIVES:
The Senior Manager, Clinical Data Ingestion is responsible for ingesting, validating, and operationalizing clinical data feeds into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) to enable efficient, high-quality clinical data review. The role builds and scales reusable ingestion frameworks, establishes monitoring and controls for vendor transfers and enterprise sources (e.g., EDC, CTMS), and manages downstream exports to enable analytics and programming teams.
ACCOUNTABILITIES:
- Ingest clinical data from EDC/CTMS and vendors (e.g., labs, eCOA, imaging, safety) into Veeva CDB/Elluminate/JReview per specifications and refresh cadence.
- Execute and support file/API loads, including mapping, transformations, referential integrity, and controlled reprocessing.
- Apply ingestion best practices: standardization, automated QC/validation, reconciliation, auditability/lineage, and incremental loads.
- Build and maintain reusable ingestion frameworks and standards (templates, metadata-driven mappings, reusable QC rules, runbooks).
- Operate transfer monitoring and ingestion operations (expected vs received, timeliness/completeness checks, alerting/escalation, scheduling/re-runs, defect triage, KPI/SLA tracking).
- Ensure datasets are review-ready and manage downstream exports with clear data contracts and refresh expectations.
- Partner with vendors/stakeholders to define/maintain transfer specs and acceptance criteria; provide SME troubleshooting and document fixes.
- Follow controlled documentation and change practices for regulated clinical processes, maintaining validation/traceability evidence and audit-ready records.
QUALIFICATIONS:
- BS/BA (or equivalent) plus 7+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support (ideally supporting clinical data review and recurring study/vendor transfers).
TECHNICAL SKILLS (Preferred/Required):
- Experience ingesting data into Veeva CDB, Elluminate, and/or JReview (or comparable clinical data review systems).
- Strong end-to-end ingestion understanding (data contracts/specifications, refresh cadence, incremental vs full loads, controlled reprocessing, reconciliation, traceable lineage).
- Ability to design/execute automated QC/validation checks; completeness/timeliness verification; reconciliation.
- Hands-on CSV/JSON/XML; file-based and/or API-based integrations; secure transfer patterns (e.g., SFTP/managed file transfer).
- Strong SQL; proficiency in Python (preferred) or similar scripting for ingestion/QC/automation.
- Experience building/using monitoring for transfers and pipelines (expected vs received, alerting, incident triage, reruns, KPI/SLA reporting).
- Working knowledge of EDC, CTMS, and vendor domains (labs, eCOA/ePRO, imaging, safety) and how feeds change over time.
- Understanding of downstream needs (data review workflows; exports to CDM/analytics/programming) and support stable, well-documented exports.
- Strong documentation discipline (specs, mappings, runbooks, issue logs) and comfort in controlled/regulated environments; preferred exposure to GxP/CSV expectations and change control.
WORKING STYLE:
- Strong cross-functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming).
- Detail-oriented, highly organized; collaborative, self-directed, proactive problem-solver; able to manage recurring operational workloads and drive issues to closure.
Application instructions:
- No Phone Calls or Recruiters Please.
The Senior Manager, Clinical Data Ingestion is responsible for ingesting, validating, and operationalizing clinical data feeds into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) to enable efficient, high-quality clinical data review. The role builds and scales reusable ingestion frameworks, establishes monitoring and controls for vendor transfers and enterprise sources (e.g., EDC, CTMS), and manages downstream exports to enable analytics and programming teams.
ACCOUNTABILITIES:
- Ingest clinical data from EDC/CTMS and vendors (e.g., labs, eCOA, imaging, safety) into Veeva CDB/Elluminate/JReview per specifications and refresh cadence.
- Execute and support file/API loads, including mapping, transformations, referential integrity, and controlled reprocessing.
- Apply ingestion best practices: standardization, automated QC/validation, reconciliation, auditability/lineage, and incremental loads.
- Build and maintain reusable ingestion frameworks and standards (templates, metadata-driven mappings, reusable QC rules, runbooks).
- Operate transfer monitoring and ingestion operations (expected vs received, timeliness/completeness checks, alerting/escalation, scheduling/re-runs, defect triage, KPI/SLA tracking).
- Ensure datasets are review-ready and manage downstream exports with clear data contracts and refresh expectations.
- Partner with vendors/stakeholders to define/maintain transfer specs and acceptance criteria; provide SME troubleshooting and document fixes.
- Follow controlled documentation and change practices for regulated clinical processes, maintaining validation/traceability evidence and audit-ready records.
QUALIFICATIONS:
- BS/BA (or equivalent) plus 7+ years in data ingestion/integration, ETL/ELT operations, or clinical data pipeline support (ideally supporting clinical data review and recurring study/vendor transfers).
TECHNICAL SKILLS (Preferred/Required):
- Experience ingesting data into Veeva CDB, Elluminate, and/or JReview (or comparable clinical data review systems).
- Strong end-to-end ingestion understanding (data contracts/specifications, refresh cadence, incremental vs full loads, controlled reprocessing, reconciliation, traceable lineage).
- Ability to design/execute automated QC/validation checks; completeness/timeliness verification; reconciliation.
- Hands-on CSV/JSON/XML; file-based and/or API-based integrations; secure transfer patterns (e.g., SFTP/managed file transfer).
- Strong SQL; proficiency in Python (preferred) or similar scripting for ingestion/QC/automation.
- Experience building/using monitoring for transfers and pipelines (expected vs received, alerting, incident triage, reruns, KPI/SLA reporting).
- Working knowledge of EDC, CTMS, and vendor domains (labs, eCOA/ePRO, imaging, safety) and how feeds change over time.
- Understanding of downstream needs (data review workflows; exports to CDM/analytics/programming) and support stable, well-documented exports.
- Strong documentation discipline (specs, mappings, runbooks, issue logs) and comfort in controlled/regulated environments; preferred exposure to GxP/CSV expectations and change control.
WORKING STYLE:
- Strong cross-functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming).
- Detail-oriented, highly organized; collaborative, self-directed, proactive problem-solver; able to manage recurring operational workloads and drive issues to closure.
Application instructions:
- No Phone Calls or Recruiters Please.