Manager, IRT Center of Excellence

Summary

This position is responsible for managing Interactive Response Technology (IRT)-related activities across multiple clinical trials and / or at the vendor level according to Good Clinical and Manufacturing Practices (GCP. GMP), and Daiichi Sankyo standard practices. A successful candidate will be responsible for providing subject matter expertise in IRT while driving the development and delivery of IRT systems across global matrixed teams.

Responsibilities

- Manage and coordinate IRT-related activities and timelines during study initiation, start-up, conduct, closeout, and archival. These activities will include:
- Providing input into the Request for Proposal (RFP) process and protocol development process for assigned clinical trials;
- Managing and contributing to the IRT system development lifecycle, including requirements gathering, user acceptance testing, issue management, change management and decommissioning activities, to minimize unanticipated impacts across programs and stakeholders;
- Supporting transparency in operational planning through tracking IRT-related milestones and dashboard inputs; and
- Ensuring inspection readiness of IRT-related items for assigned clinical trials.
- Conduct oversight of assigned IRT vendors, ensuring timelines and data quality standards are met.
- Lead and/or contribute to cross-functional and global improvement projects including IRT-related data and/or IRT vendors.
- Support compliance audits, IRT vendor audits and regulatory inspections.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

- Bachelor's Degree Degree in Science or related field. Extensive relevant experience will be considered in lieu of an advanced degree. required
- Master's Degree Degree in Science or related field. preferred

Experience Qualifications

- Minimum 8 years of related experience in life sciences or medically related field including 6 years of supporting pharmaceutical/biopharmaceutical clinical research experience (obtained by working on clinical trials at a pharmaceutical, biopharmaceutical, CRO or relevant vendor) required
- Minimum of 4 years direct experience leading IRT-related projects with cross-functional stakeholders preferred preferred
- Experience leading IRT-related projects across global teams preferred preferred
- Oncology experience is preferred preferred

Travel:

Ability to travel up to 20% Single day/Overnight/Multi-day travel will be required to go to outsourced vendors or company offices.