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Job Description
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-Google Cloud Platform 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 build relationships in a matrix organization.
- Strong mentoring and training capabilities with attention to detail and commitment to quality and compliance.
- Advanced proficiency with Microsoft Office applications; experience with TMF systems and clinical data platforms.
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:
Boston, MA
U.S. Base Salary Range:
$116,000.00 - $182,270.00
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.
For information about our benefits, please click .
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Boston, MA
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.
