Manager, IRT Center of Excellence Job at Daiichi Sankyo, Inc.
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
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.
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