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Job Description
Objective / Purpose:
The Associate Director (AD), Clinical Data Management (CDM) is responsible for timely and high-quality CDM deliverables in support of Takeda global development programs, post-marketing registrational and non-registrational studies, providing support at the program, group of programs, and/or portfolio level.
The AD, CDM may be responsible for oversight of CDM activities conducted within Takeda or by strategic partners, CROs, or other third-party vendors; ensuring obligations are met as described in ICH-GCP, and Takeda’s Scope of Work.
The AD, CDM champions accelerating the adoption and effectiveness of CDM tools/technologies and are responsible for providing leadership and consultative expertise in initiatives, and for promoting operational efficiency and process excellence (e.g. regulatory submissions, inspections, lessons learned).
The AD, CDM provides subject matter expertise and enables solutions for complex problem-solving that aligns with the Takeda values. This role operates as a recognized expert with in-depth knowledge of the CDM discipline having broad impact on the business that affects operations within and across Therapeutic Area Units (TAU) and the department.
The AD, CDM may have direct line management responsibilities and/or supervisory responsibility of global Functional Service Providers (FSPs).
Accountabilities:
Responsibilities may include:
• Direct line management and/or mentoring and coaching to CDM team members: o Provides line management of direct report employees by establishing performance goals, providing ongoing mentoring, soliciting feedback from stakeholders and providing an open line of communication for feedback and support, including the delivery of performance reviews.
Provides timely performance feedback to direct line managers for CDM staff assigned to projects.
Supervises FSP staff, vendors, and contractors.
• Accountable for overall delivery of CDM deliverables and project execution:
Provides oversight (or direct support as needed) of CDM activities for studies and programs conducted within Takeda, or by strategic partners, CROs, or other third-party vendors; ensuring obligations are met as described in ICH-GCP, and Takeda’s Scope of Work.
Represents CDM function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all CDM related deliverables, especially in support of key decision points and regulatory submissions.
Accountable for the achievement of major CDM deliverables and milestones in coordination with the cross-functional Study Execution Team (SET).
Accountable for the planning and management of external CDM budgets (in collaboration with Clinical Operations TAU Leads) to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Provides oversight into the quality and timely creation and maintenance of data collection tools (e.g. EDC, IRT, ePRO, eCOA), study data cleaning plan components, including edit checks, listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans.
Ensures comprehensive and current data review is maintained during the study, including query management, and oversee/leads activities required for interim and final database locks.
Ensures archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
Participates in preparing function for submission/inspection readiness and may represent function in a formal inspection, audit, or regulatory…