Senior Manager, Clinical Data Management

Role Summary

Senior Manager, Clinical Data Management (Remote) responsible for delivering timely, high-quality data management deliverables across Takeda's portfolio. Manages oversight of data management activities at the project or program level, including in-house and vendor-driven work, to ensure they meet obligations described in ICH-GCP and the scope of work, maximize effectiveness, and maintain budgets. Leads cross-functional teams, mentors junior staff on CDISC standards, and guides data capture tools (EDC, IRT, ePRO, eCOA). Location: Massachusetts – Virtual (remote per policy); travel expected up to 5–20% domestically/internationally.

Responsibilities

• Lead data management activities for in-house and outsourced studies; may manage staff responsible for performing those activities.
• Oversee vendor activities across global development programs; represent data management on the Clinical Sub-team to align CRO and Takeda for data deliverables and regulatory submissions.
• Provide influential leadership to ensure milestones and deliverables are met with high quality; mitigate and resolve risks with stakeholders and CRO partners.
• Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Lead data collection setup, data review, and database lock for studies conducted within Takeda; coordinate setup of EDC and study data collection tools (IRT, ePRO, eCOA).
• Develop and maintain study data cleaning plan components, including edit checks, listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, SAE reconciliation guidelines, and database lock plans.
• Lead data review, including query management, and lead activities required for interim and final database locks; may oversee these activities at the program level.
• Participate in preparation for submission readiness and may represent the function in inspections or audits; ensure archival and inspection readiness of TMF documents.
• Coordinate with other functions to achieve major data management deliverables and milestones, including the Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics.
• Responsible for planning and management of external Data Management budgets and timelines to ensure accuracy, understand variances, and support continuous improvement in forecasting.
• Act as a process expert for operational and oversight models; maintain SOPs, process maps, templates, and timelines to support functional operations.
• Champion technology improvements and tools for use in clinical data management processes; promote knowledge sharing and ensure alignment with learning curricula and GXP requirements.
• Performs other duties as assigned.

Qualifications

• Required: BS/BA in health-related, life science, or technology-related fields.
• Preferred: 6+ years of experience in data management and/or drug development with cross-functional interfaces to the data management function.
• Preferred: Proven track record of strong project management and experience managing data management activities for large drug development programs.
• Preferred: Experience with all phases of development in one or more therapeutic areas; ability to handle multiple development programs simultaneously.
• Preferred: NDA/CTD experience.
• Required: Strong knowledge of data management best practices and technologies as applied to clinical trials; solid understanding of clinical trial documents (protocols, SAPs, CRFs, study reports) and processes.
• Required: Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management; advanced knowledge of the broad drug development process with cross-functional interfaces.

Skills

• Advanced knowledge of Microsoft Office; proficiency with relational databases and multiple CDM systems.
• Budget planning and management experience.
• Good working knowledge of medical coding, dictionaries, coding tools, and coding governance models.
• Expert knowledge of CDISC standards, with SDTM preferred; experience leading standards selection and implementation in clinical trials.
• Strong understanding of medical terminology, coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology, and disease processes.

Education

• BS/BA required, preferably in health-related, life science, or technology-related fields.

Additional Requirements

• Domestic/international travel up to 5–20% may be required.
• Remote/work location: Massachusetts - Virtual; remote work policy applies.