Sr Manager, Third Party Data Acquisition

OBJECTIVES/

PURPOSE:

• • The Senior Manager, Third-Party Data Acquisition (TPDA) is accountable for ensuring the integrity, compliance, and timely delivery of non-EDC data from third-party vendors throughout the data lifecycle for assigned studies and programs.
  • Performs TPDA activities at the study and program level, ensuring adherence to applicable study documentation, Takeda quality processes, and regulatory standards.
• Trains and mentors Managers and Coordinators on department processes and standards, supports departmental initiatives, and provides subject matter expertise to support clinical development programs.

ACCOUNTABILITIES:

• Performs TPDA activities for assigned studies and programs to ensure compliance, quality, and audit readiness.
• Serves as escalation point for study and program-level issues and collaborates with cross-functional stakeholders to support study objectives.
• Monitors data deliverables across assigned studies and programs to identify, resolve, and prevent inconsistencies in process and standards adherence.
• Trains and mentors Managers and Coordinators on TPDA processes, standards, and best practices.
• Contributes to assigned departmental initiatives focused on process improvements.

Technical Expertise

• Comprehensive knowledge of end-to-end third-party data integration processes, including validation, operationalization, and ongoing optimization.
• Experience working effectively in complex matrix environments with cross-functional stakeholders, understanding their roles in data generation, acquisition, ingestion, summarization, and reporting across a large clinical portfolio.
• Strong understanding of clinical data standards (CDISC, SDTM, ADaM), data governance practices, and diverse data formats and structures across non-EDC technologies, including eCOA, IRT, laboratories, wearables, imaging, and other third-party data sources.
• Stays current with non-EDC clinical data acquisition technologies and supports adoption across studies.

Leadership

• Provides hands-on execution of planning, setup, transfer, and acquisition of third-party clinical data across assigned studies and programs, ensuring alignment with study objectives and regulatory requirements.
• Trains and mentors Managers and Coordinators on TPDA processes, standards, and vendor and study specific considerations.
• Collaborates effectively with cross-functional stakeholders to drive alignment and informed decision-making, and supports change management for assigned process improvements and departmental initiatives.

Interaction

• Performs study and program-level activities, building collaborative relationships with cross-functional teams and external stakeholders within a complex matrix environment.
• Manages timely delivery of TPDA deliverables across multiple concurrent programs.
• Engages with external vendors to facilitate alignment on processes, expectations, and issue resolution at the study and program levels.
• Represents TPDA in study and program team meetings, supports regulatory inspections and audits, and participates in departmental and company-wide initiatives as assigned.

Complexity

• Manages multiple concurrent studies with unique data acquisition requirements across various therapeutic areas and development phases.
• Navigates complex matrix organization with multiple stakeholders and competing demands, coordinating across functional groups while managing resource constraints and vendor capabilities.
• Works with diverse vendor types and technologies, and adapts to evolving regulatory landscape and pharmaceutical development environment.

EDUCATION, BEHAVIOURAL COMPETENCIES AND

SKILLS:

• BS/BA required in health-related, life science, or technology-related fields with minimum 6+ years of drug development experience
• Solid understanding of clinical trial processes, documents, ICH-GCP and global regulatory requirements, industry standards, and quality control principles with ability to explain and train others.
• Extensive experience managing the acquisition, integration, and oversight of external clinical data from third-party vendors, including vendor relationship management, overseeing delivery, and ensuring data harmonization and validation for seamless integration with Clinical Data Warehouses and analytics platforms.
• Excellent project management, organizational, problem-solving, and analytical skills with ability to manage multiple priorities and adapt to changing demands.
• Effective communication and collaboration skills across functional groups with proven ability to…