- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **Purpose:** The purpose of the Clinical Trial Quality Associate - Global Medicines Quality ... development and implementation of the strategy for **Good Clinical Practice (GCP)** quality systems and activities...functional areas such as medical writing, regulatory affairs, or clinical trial management + Ability to work… more
- Sumitomo Pharma (Indianapolis, IN)
- …Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. ... Partnering with the Associate Director, Clinical Business Operations, the specialist...the study TMF. **Key Responsibilities** + Responsible for overall quality , maintenance, and completeness of Trial Master… more
- Parexel (Indianapolis, IN)
- …associated with the set-up, running and close-out of sites in a clinical trial . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is... + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites… more
- Parexel (Indianapolis, IN)
- …activities associated with the set-up, running and close-out of sites in a clinical trial . **Monitoring Responsibilities and Study Conduct:** + Ensure proper ... The Senior Clinical Research Associate (Sr. CRA) is... + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites… more
- ThermoFisher Scientific (Indianapolis, IN)
- …research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will ... study systems are updated per agreed study conventions (eg Clinical Trial Management System, CTMS). Performs QC...perform the job (comparable to 2+ years as traveling clinical research associate ). Valid driver's license where… more
- Lilly (Indianapolis, IN)
- …+ Leverage robust knowledge of multiple inventory methodologies to collaborate with Clinical Trial Study Management and facilitate optimal Supply Planning. + ... support questions. + Maintain GMP/GCP compliance by following procedures applicable to clinical trial execution. + Actively participate in external inspections… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, ... products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of... clinical , statistical, and regulatory literature for current clinical trial results, regulatory trends and new… more
- Bristol Myers Squibb (Indianapolis, IN)
- …the Sr. Warehouse Associate shall provide tactile support for all clinical trial and future commercial receiving, material handling, shipping and ... Located at our Indianapolis, IN site, the Sr. Warehouse Associate will be responsible for warehousing support related to...related to domestic and international shipping and distribution of clinical trial and commercial products for RayzeBio… more
- ThermoFisher Scientific (Indianapolis, IN)
- …research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will ... support by performing day-to-day functions within the client organization to support clinical trial activities. **A Day in the Life:** Administrative type… more
- Lilly (Indianapolis, IN)
- …develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental ... impact. The Associate Director of Materials will lead the planning and...quality standards. + Develop contingency strategies for critical clinical materials to protect study timelines. **Basic Requirements:** +… more
- Lilly (Indianapolis, IN)
- …develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental ... impact. The Associate Director Small Molecule Process Engineering provides leadership and...site evolves from a design concept to a GMP clinical trial site. **Key Responsibilities:** + Responsible… more
- Sumitomo Pharma (Indianapolis, IN)
- …regulatory submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to ... a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part… more
- Lilly (Indianapolis, IN)
- …develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental ... impact. **Position Description:** The Associate Director Operational Readiness is responsible for managing the delivery of operational readiness aspects of the… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …+ Ensure regulatory intelligence specialists have continued access to regulatory, clinical trial , and public domain information resources to identify ... The Associate Director of Regulatory Intelligence leads the collection...taxonomy terms relevant to Otsuka approved and investigational products, clinical , and business development programs. + Build professional network… more
- Lilly (Indianapolis, IN)
- …cross-functional initiatives to optimize system integration and data exchange between clinical trial management systems (CTMS), safety databases, commercial ... case management capabilities. The role oversees ICSR activities and case quality , including data analysis, trend reporting, KPIs, and business insights, while… more
- Lilly (Indianapolis, IN)
- …develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental ... molecules. The Supervisor ensures the team consistently employes a safety-first, quality -always approach while managing a production process that encompasses diverse… more