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Job Description
OBJECTIVES/PURPOSE:
- The Associate Director, Third-Party Data Acquisition (TPDA) is accountable for ensuring the integrity, compliance, and timely delivery of non-EDC clinical trial data acquired from third-party vendors throughout the data lifecycle.
- Provides operational leadership and execution oversight for day-to-day TPDA activities, ensuring team adherence to applicable study documentation, Takeda quality processes, and regulatory standards.
- Drives consistency, scalability, and continuous improvement of TPDA practices, leading departmental initiatives, enforcing standardized data transfer approaches, and serving as a subject matter expert in support of clinical development programs and regulatory inspections.
ACCOUNTABILITIES:
- Provides oversight of TPDA activities for assigned studies and programs to ensure compliance, quality, and audit readiness.
- Oversees day-to-day TPDA operations, including work prioritization, resource allocation, and quality oversight of team deliverables to ensure adherence to established processes and standards.
- Conducts performance reviews and addresses performance issues, manages development of direct reports, and recruits for open positions.
- Drives and owns assigned departmental initiatives focused on process improvements, training development, standardization, and workflow efficiency across TPDA activities.
- Serves as escalation point for complex issues related to TPDA and collaborates with cross-functional stakeholders to support study objectives and regulatory compliance.
- Monitors data deliverables across studies, programs, and vendors to identify, resolve, and prevent inconsistencies in process and standards adherence.
DIMENSIONS AND ASPECTS:
- Technical Expertise
- Comprehensive knowledge of end-to-end third-party data integration processes, including strategy, validation, operationalization, and ongoing optimization.
- Highly effective at partnering with internal and external stakeholders to drive alignment on comprehensive solutions and practices that are scalable for data transfer, ingestion, and reporting across a large clinical portfolio.
- Expert knowledge of clinical data standards (CDISC, SDTM, ADaM), data governance practices, and diverse data formats and structures required to ensure integrity, interoperability, and regulatory compliance of third-party data.
- Deep understanding of non-EDC clinical data acquisition technologies, emerging solutions, and their strategic application across studies and therapeutic areas.
- Leadership
- Provides leadership for the planning, setup, transfer, and acquisition of third-party clinical data across the portfolio, ensuring alignment with business priorities and regulatory requirements.
- Supports the strategic vision for evolving TPDA infrastructure and processes toward enterprise-level standardization, partnering with cross-functional leaders and vendors to design and implement scalable solutions that enhance efficiency and consistency.
- Develops and supports a high-performing TPDA team through mentoring, performance management, and fostering a culture of innovation and accountability.
- Collaborates effectively with cross-functional stakeholders to drive alignment and informed decision-making, communicates across all organizational levels, and leads change management for departmental process improvements and initiatives.
- Decision-making and Autonomy
- May have line management responsibilities for TPDA team members and/or contractors, making independent decisions on day-to-day operations, work prioritization, issue resolution, and providing input on resource allocation and strategic direction.
- Interaction:
- Leads complex, cross-organizational projects and builds collaborative relationships with cross-functional teams and external stakeholders to drive TPDA and business process improvements within a complex matrix environment.
- Oversees timely delivery of TPDA deliverables across multiple concurrent programs using risk-based prioritization, and supports study leads in developing comprehensive solutions when issues arise.
- Engages with external vendors in high-stakes discussions to facilitate alignment on processes, expectations, and issue resolution, ensuring service delivery meets quality and compliance standards.
- Supports vendor oversight activities and governance models including vendor performance evaluation and technical audits, drives TPDA process improvements, and represents TPDA in cross-organizational process initiatives.
- Represents TPDA in regulatory inspections and audits, departmental and company-wide initiatives, and serves as subject matter expert in cross-functional organizational discussions.
- Innovation:
- Identifies opportunities to streamline and automate departmental processes, staying current with emerging data types, digital endpoints, and new technologies in clinical trials.
- Supports implementation of innovative solutions, shares knowledge and best practices across the organization, and contributes to continuous improvement culture.
- Complexity:
- Manages high complexity programs with multiple concurrent studies, projects, and data platforms across various therapeutic areas and development phases, each with unique data acquisition requirements.
- 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, 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; MS preferred.
- 8+ years of pharmaceutical/biotechnology drug development experience in clinical data acquisition, management, or related clinical operations roles.
- Prior lead or supervisory experience preferred.
- Strategic knowledge of clinical trial processes, documents, ICH-Google Cloud Platform and global regulatory requirements, industry standards, and quality control principles.
- Extensive experience managing the acquisition, integration, and oversight of external clinical data from third-party vendors including laboratory data, eCOA, imaging, wearable device data, and emerging data types.
- 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 coaching 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 preferred.
- undefined
This position is currently classified as ?hybrid? in accordance with Takeda?s Hybrid and Remote Work policy.
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:
$154,400.00 - $242,550.00
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.
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