- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and understanding of the need to address such issues or concerns. Experience with IRT systems and support in managing the forecasting and planning of drug supply ... able to communicate the issues and support resolution development.Support IRT design for control of drug dispensing and inventory...and inventory management. Understand User specifications in support of IRT processes and basic concepts of IRT … more
- BeOne Medicines (San Mateo, CA)
- …external supply partners. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with ... (eg Regulatory, Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing, develop IRT supply...+ Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply… more
- BeOne Medicines (San Mateo, CA)
- …external supply partners. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with ... (eg Regulatory, Clinical Operations, CRO) and CMOs. + Support IRT user acceptance testing, develop IRT supply...+ Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply… more
- Insmed Incorporated (NJ)
- …and implement comprehensive sourcing strategies, engaging CMOs, CROs, 3PLs, IXRS/ IRT vendors and other third-party providers in alignment with clinical ... development and Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and continuous improvement reviewsEstablish and maintain KPIs, scorecards, and… more
- Insmed Incorporated (NJ)
- …role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT , eCOA/ePRO and other Clinical/Manufacturing systems.Minimum of a Bachelor's Degree in ... Computer Sciences, Engineering, or related fieldProject lead experience preferred.Strong experience in Clinical Study Systems is required.Experience in evaluating and validating AI solutions in regulated uses is preferred.Experience with Veeva QualityDocs… more
- Genmab (NJ)
- …approve randomization and stratification plansPerform UAT of Randomization part of the IRT system as applicableEnsure procedures for blinding are in place as ... applicableSupport timely delivery of statistical deliverablesResponsible for planning and conducting trial result meetingsReview and approve the CSRAttend operational and steering committee meetings, as applicableSupport regulatory submission/filing… more
- Carnegie Mellon University (Pittsburgh, PA)
- …among staff and users. + Work with trusted partners/projects (CMU/Pitt/HuBMAP/Neocortex/BIL) IRT cybersecurity projects and programs. + Serve as a [CP}ISO on ... related projects (Neocortex, HuBMAP, BIL, SenNet, ACCESS, etc + Regularly report to PSC management on information security posture and oversee scheduled security training for staff and users. + Acts as team leader. Determines own and team's priorities based on… more
- BeOne Medicines (San Mateo, CA)
- …+ Process modeling + Familiarity with clinical applications eg CTMS, EDC, IRT **Soft skills:** + **Stakeholder management** : Ability to work collaboratively with ... functional leadership and external partners, to forge partnerships and collaborations arrangements. Ability to manage expectations, to communicate to broad groups of end-users. + **Communication** : Exhibits strong cross-cultural awareness, and strong verbal… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …audit readiness. + Coordinate with EDC and other data vendors (eg, ePRO, IRT , central labs), ensuring seamless integration and data flow. + Represent data management ... in study team meetings and regulatory audits or inspections. + Ensure completeness, correctness and consistency of clinical data and data structure across projects. + Ensure accurate tracking and reporting of study metrics and timelines. + Proactively drives… more
- BeOne Medicines (Emeryville, CA)
- …for the Import and export permit application as needed. + Understand how to use IRT to check shipment status as needed. + Ensure the logistics data entry and ... documents uploading in BeOne systems could be performed accurately and timely as per BeOne related procedures. + Support on BeOne IOR and import tax deferral setup, managing BeOne IOR in different countries, giving greenlight approval and supporting the… more
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