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Job Description

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, Clinical Data Enablement based remotely reporting to the Director, Clinical Data Engineering.

GOALS:

The Associate Director, Clinical Data Enablement will lead Clinical Data Delivery & Ingestion. Owns end-to-end clinical data delivery across ingestion, integration, operational monitoring, and downstream consumption. This role leads the delivery of data into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) as well as enterprise data lake/warehouse ecosystems, ensuring data is review-ready, reliable, traceable, and compliant. The role also provides delivery leadership by leading/mentoring FSPs and driving scalable frameworks, standards, and operational excellence.

Accountabilities:

• Own end-to-end clinical data delivery from source transfers to ingestion to review platforms to lake/warehouse  downstream exports, ensuring stable, performant, and traceable operations.
• Define delivery plans, prioritize work, and drive execution across multiple concurrent studies and vendor feeds; manage delivery risks, dependencies, and release schedules.
• Establish and manage SLAs/OLAs, delivery KPIs, and service health reporting (timeliness, completeness, quality, incident trends).
• Build and evolve a reusable ingestion/integration framework (metadata-driven mappings, standardized templates, reusable QC rules, automation utilities, runbooks) to accelerate onboarding and improve consistency across studies/vendors.
• Automate operational workflows (scheduling, exception handling, automated quality checks) to improve reliability, repeatability, and cycle time.
• Lead design and operation of clinical data pipelines across data lake/warehouse environments, including build/run/monitor/troubleshoot responsibilities.
• Build and scale cloud-based ETL/ELT capabilities (AWS/Azure) for efficient ingestion, transformation, orchestration, and delivery to downstream data products and analytics needs.
• Provide SME troubleshooting and standardize fixes (documentation/reusable controls).
• Define/maintain transfer specs, mappings, acceptance criteria, and reconciliation with vendors and stakeholders.
• Align downstream outputs/exports with SDTM/Stats/Analytics/CDP needs (format/cadence).
• Ensure GxP/CSV compliance (documentation/traceability/audit readiness) and embed data integrity (ALCOA+) controls with Quality/Compliance/IT.
• Lead and mentor junior staff and FSPs through technical guidance, delivery planning, code/config reviews, and establishing team standards and best practices.
• Promote consistent ways of working (documentation, runbooks, onboarding playbooks, design patterns) to scale delivery and reduce key-person dependency.

EDUCATION AND EXPERIENCE:

• 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 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.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Massachusetts - Virtual

U.S. Base Salary Range:
$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Locations
Massachusetts - Virtual

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.