Supporting Takeda1. Managing/owning workflows for regulatory-owned Module 1 documents.2. Conduct final QC of output and release for FDA submission.3. HA response coordination.4. FDA Annual Report Coordination5. Review quarterly/annual RIMS and GRACE reports to ensure information is up to date.6. Track FDA Submissions and Approvals for CTA in the log7. Track Substantial IB updates in the Tracking form.8. Update the Product Responsibility List9.Periodic and Final eTMF QC of Regulatory documents10. Population of Content Plan Template with specifics for submission and metadata (for non-SWG supported submissions); management and ownership of content plan; and orchestration of submission with cross-functional team and publishers.

1. Responsible for planning, managing, and overviewing of study set-up, closeout, & study information like regulatory documents, Trial Master File, enrollment, Adverse Events / Serious Adverse Events, site supplies, Institutional Review Board re-approvals, data queries on a variety of databases and systems.2. Responsible for participating in study-related meetings & action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings).

1. Maintains effective and ongoing communication with sponsor, research participants and PI during the study period.2. Coordinating to Design & implementation of all the aspects of the project.3. Presentations for customers detailing project scope, progress and results.4. Performed billing and other project management administrative tasks to help projects on schedule and within budget5. Assessed project progress and created project status reports to keep project managers and stakeholders6. Responsible for managing and overviewing of study related activities.7. Works with the PI to develop and implement recruitment strategies in accordance with IRB/IEC requirements and approvals8. Collaborates with the investigators and department to prepare a categorized budget and justification. 9. Preparation of periodic study updates and coordination with project manager for providing study updates or any operational documents to sponsor.10. Reviews and develops a familiarity with the protocol, like; study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.