Senior Manager, Clinical Data Ingestion

Role Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Clinical Data Ingestion in our Cambridge, MA office.

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.
• Focusing on strong ingestion principles, building and scaling reusable ingestion frameworks, and establishing monitoring and controls for vendor transfers and enterprise sources (e.g., EDC, CTMS).
• Managing 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 a reusable ingestion framework and standards (templates, metadata-driven mappings, reusable QC rules, runbooks) to accelerate onboarding and improve consistency.
• Operate transfer monitoring and ingestion operations: expected vs received, timeliness/completeness checks, alerting/escalation, scheduling/re-runs, defect triage, and KPI/SLA tracking.
• Ensure datasets are review-ready and manage downstream exports to internal consumers with clear data contracts and refresh expectations.
• Partner with vendors and stakeholders to define/maintain transfer specs and acceptance criteria; provide SME troubleshooting and document fixes for repeatable operations.
• Follow controlled documentation and change practices for regulated clinical processes, maintaining validation/traceability evidence and audit-ready records as required.

Qualifications

• BS/BA (or equivalent) plus 7+ years in data ingestion/integration.
• Experience in ETL/ELT operations or clinical data pipeline support, ideally supporting clinical data review and recurring study/vendor transfers.

Requirements

• Preferred platform exposure: Experience ingesting data into Veeva CDB, Elluminate, and/or JReview (or comparable clinical data review systems).
• Strong understanding of end-to-end ingestion concepts including data contracts/specifications, refresh cadence, incremental vs full loads, controlled reprocessing, reconciliation, and traceable lineage.
• Ability to design/execute automated QC/validation checks, completeness/timeliness verification, and reconciliation routines to ensure datasets are review-ready.
• Hands-on experience with CSV, JSON, XML and file-based and/or API-based integrations; familiarity with secure transfer patterns (e.g., SFTP/managed file transfer concepts).
• Strong SQL skills; working proficiency in Python (preferred) or similar scripting to automate ingestion, QC, parsing, and operational tasks.
• Demonstrated ability to build or extend reusable ingestion components (metadata-driven mappings, templates, reusable QC rules, standard runbooks).
• Experience building/using monitoring for transfers and pipelines (e.g., expected vs received, timeliness/completeness checks, alerting, incident triage, reruns, KPI/SLA reporting).
• Working knowledge of common clinical sources such as EDC, CTMS, and vendor domains (e.g., labs, eCOA/ePRO, imaging, safety) and how those feeds typically arrive and change over time.
• Understanding of downstream consumption needs (data review workflows, exports to CDM/analytics/programming) and ability to support stable, well-documented exports.
• Strong documentation discipline (specs, mappings, runbooks, issue logs) and comfort operating in controlled/regulated environments.
• Exposure to GxP/CSV expectations, change control, and maintaining audit-ready operational evidence (as applicable to the organization/process).
• Strong cross-functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming).
• Detail-oriented, highly organized, strong collaboration and communication; organized, self-directed, proactive problem-solver and able to manage recurring operational workloads while driving issues to closure and preventing recurrence.

Benefits

• U.S. Base Salary Range: $137,000.00 - $215,270.00.
• Eligible for short-term and/or long-term incentives.
• Participation in medical, dental, vision insurance, a 401(k) plan and company match.
• Short-term and long-term disability coverage, basic life insurance.
• Tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits.
• Eligible for up to 80 hours of sick time per calendar year.
• New hires are eligible to accrue up to 120 hours of paid vacation.