Associate Director
vor 1 Tag
**_ Summary:_**_ The primary responsibility of the Associate Director, Clinical Trial Transparency role within CTT is to ensure global clinical transparency policies reflect Takeda’s commitments to integrity, transparency, and core values internally and externally, through oversight, and implementation of process-driven activities that result in timely and high-quality posting of clinical trial information to the public domain. This role ensures disclosure activities are implemented in full compliance with Takeda policies and applicable requirements globally, while providing regulatory strategy and intelligence assessments, in addition to maintaining oversight of the evolving external landscape. In addition, this role supports broader patient-centric access to information, facilitates external innovation and partnership through access to information and data._
**_ Scope of Accountability/Responsibility:_**
- Management of processes and standards to support clinical trial (CT) disclosure requirements including protocol registration & results posting and other activities that support Takeda business objectives within the scope of Clinical Trial Transparency by delivering maximum transparency while respecting general and national data protection regulations.
- Sponsor oversight tasks relating to oversight of study protocol registration, posting of results from clinical study reports (CSRs) and other clinical documents for public disclosure under Takeda Policies and Processes. The function ensures CT registration and result posting within timelines, in accordance with team goals, current and future regulatory requirements, as well as continuity and consistency of clinical data from concept to disclosure.
- Develops, implements and verifies that transparency plans are executed according to milestones and requirements and escalates any at risk or compliance issues to management.
- Monitors metrics of disclosure activities and evaluates needs to alter process to maximize efficiencies and compliance.
- Supports establishment of best practices for operational excellence to ensure value-added access to clinical trial data and an improved user experience on Takeda’s CTT information platform.
- Develops routine compliance checks to support constant active management of transparency compliance. Implements in depth compliance oversight leveraging internal/external resources to ensure compliance and effectively implement corrective actions
- Vendor(s) management to ensure continuity of services and that maximum cost-savings are maximized in parallel with the level/quality of service.
- Supports internal Takeda transparency communication and participation in internal (eg: cross-functional initiatives) and external industry groups/committees.
**_ Key Responsibilities:_**
- _ Manage changes associated with new transparency regulations and requirements at Takeda (eg CTIS portal submissions, lay summary capability to support EU CT regulation)_
- _ Drive the processes and standards for disclosure and transparency activities resulting in timely, high-quality information posted to public websites, ensuring Takeda’s corporate goal/metric of 100% timely results disclosure of all Phase 1-4 trials is met._
- _ Support optimization of CTT’s vendor operating model _
The Associate Director, CTT reports to the Head, Clinical Trial Transparency (Sr. Director).
**Locations**:
AUT - Wien - DC Tower
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
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