Associate Director, Third Party Data Acquisition

3316 Takeda Development Center Americas•Boston, MA

9d•Hybrid

About The Position

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.

Requirements

BS/BA required in health-related, life science, or technology-related fields
8+ years of pharmaceutical/biotechnology drug development experience in clinical data acquisition, management, or related clinical operations roles.
Strategic knowledge of clinical trial processes, documents, ICH-GCP 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

Nice To Haves

MS preferred
Prior lead or supervisory experience preferred
experience with TMF systems and clinical data platforms preferred

Responsibilities

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.