Senior Manager, Clinical Data Management (Oncology)

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Job Description

Objective / Purpose:

The Senior Manager Clinical Data Management is responsible for timely and high quality data management deliverables supporting the Takeda portfolio. They are responsible for conducting oversight of Data Management activities at the project or program level - as performed within Takeda or by Strategic Partners, CROs or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.

The Senior Manager Clinical Data Management provides and enables solutions for complex problem solving that align with the Takeda values. They establish Project or Program level strategies and services, and are responsible for the management of vendor partnerships to maximize effectiveness and maintain budgets.

The Senior Manager Clinical Data Management serves as an expert for clinical data management, whether directly or by way of managing or mentoring other [junior] CDM Staff. They will lead cross-functional team members to perform proper Data Reviews, and provides guidance on CDISC standards.

Accountabilities:

• Responsible for leading data management activities for in-house and outsourced studies; may manage staff responsible for performing those activities.
• Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.
• Contributes influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
• Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.
• Provides input to functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
• For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set-up, data review, and database lock:

Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. Leads data review, including query management, and leads activities required for interim and final database locks. May oversee above activities at the program level.

• Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support