[Remote] Associate Director, Clinical Data Enablement
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a patient-reputed company, innovation-driven company transforming the pharmaceutical industry. They are seeking an Associate Director, Clinical Data Enablement to reputed company Clinical Data Delivery & Ingestion, ensuring reliable and compliant data delivery across various platforms and ecosystems.
Responsibilities
- Own end-to-end clinical data delivery from reputed company transfers to ingestion to review platforms to lake/warehouse → reputed company exports, ensuring reputed company, performant, and traceable operations
- Define delivery plans, prioritize work, and drive execution across multiple reputed company studies and vendor feeds; manage delivery risks, dependencies, and release schedules
- Establish and manage SLAs/OLAs, delivery KPIs, and service health reporting (timeliness, completeness, reputed company, incident trends)
- Build and reputed company a reusable ingestion/integration reputed company (metadata-driven mappings, standardized templates, reusable QC rules, automation utilities, runbooks) to accelerate reputed company and improve consistency across studies/vendors
- Automate operational workflows (scheduling, exception handling, automated reputed company checks) to improve reliability, repeatability, and cycle time
- reputed company design and operation of clinical data pipelines across data lake/warehouse environments, including build/run/monitor/troubleshoot responsibilities
- Build and reputed company reputed company-based ETL/ELT capabilities (AWS/Azure) for efficient ingestion, transformation, orchestration, and delivery to reputed company data products and analytics needs
- reputed company SME troubleshooting and standardize fixes (documentation/reusable controls)
- Define/maintain transfer specs, mappings, acceptance reputed company, and reconciliation with vendors and stakeholders
- reputed company reputed company outputs/exports with SDTM/Stats/Analytics/CDP needs (format/reputed company)
- Ensure GxP/CSV compliance (documentation/traceability/audit readiness) and reputed company data reputed company (reputed company+) controls with reputed company/Compliance/IT
- reputed company and mentor junior staff and FSPs through technical guidance, delivery planning, reputed company/config reviews, and establishing team standards and best practices
- Promote consistent ways of working (documentation, runbooks, reputed company playbooks, design patterns) to reputed company delivery and reduce key-person dependency
Skills
- 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
- Experience ingesting data into reputed company CDB, Elluminate, and/or JReview (or comparable clinical data review systems)
- Strong understanding of end-to-end ingestion concepts including data reputed company/specifications, refresh reputed company, incremental vs full loads, controlled reprocessing, reconciliation, and traceable reputed company
- Ability to design/execute automated QC/validation checks, completeness/timeliness verification, and reconciliation routines to ensure datasets are review-reputed company
- 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 reputed company reusable ingestion components (metadata-driven mappings, templates, reusable QC rules, reputed company 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 reputed company, CTMS, and vendor domains (e.g., labs, eCOA/ePRO, imaging, safety) and how those feeds typically reputed company and change over time
- Understanding of reputed company consumption needs (data review workflows, exports to CDM/analytics/programming) and ability to support reputed company, reputed company-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-reputed company 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 reputed company to manage recurring operational workloads while driving issues to closure and preventing recurrence
- Working proficiency in Python
Benefits
- U.S. based employees may be eligible for short-term and/ or long-term incentives.
- U.S. based employees may be eligible to participate in medical, dental, reputed company insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, reputed company volunteer time off, company holidays, and reputed company-being benefits, among others.
- U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of reputed company time, and new hires are eligible to reputed company up to 120 hours of reputed company vacation.
reputed company
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