Associate Director

vor 1 Woche

Wien, Wien, Österreich Takeda Pharmaceutical Vollzeit

_ 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.
  • Provides support for process development, early adoption of new regulations and risk minimization related to contradicting national regulations
  • 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 valueadded access to clinical trial data
  • 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 costsavings are maximized in parallel with the level/quality of service.
  • Supports internal Takeda transparency communication and participation in internal (eg: crossfunctional initiatives) and external industry groups/committees.

_ Key Responsibilities:
_
- _Provide training on clinical trial disclosure requirements and expectations for other functions within Takeda._
- _ Drive the processes and standards for disclosure and transparency activities resulting in timely, high-quality information ensuring Takeda's corporate goal/metric of 100% timely results disclosure of all Phase 1-4 trials is met. _
- _Acts as lead for transition of transparency related items/assets from/to the Clinical Trial Transparency team._

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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