- Taiho Oncology (Princeton, NJ)
- … operations practices and processes ensuring consistent delivery across studies . Education/Certification Requirements: + Associate 's degree or equivalent. ... impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of...dynamic team cultivating growth and learning. Position Summary: The Study Associate (SA) I is responsible for… more
- Sumitomo Pharma (Trenton, NJ)
- …Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations , the specialist ensures ... and system work instructions. Provide support and guidance to study team members during the full lifecycle of the...ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure… more
- Bristol Myers Squibb (Princeton, NJ)
- …aspects of study design. + In collaboration with Medical Writing and Clinical Operations , prepares study protocols, amendments, specific sections of ... to, collaboration on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting, and… more
- Parexel (Trenton, NJ)
- …or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is...Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction,… more
- Sumitomo Pharma (Trenton, NJ)
- …director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators ... highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology**...and study staff. + Responsible for leading clinical study teams, monitoring overall study… more
- J&J Family of Companies (Horsham, PA)
- …IBD HCP and investigator interactions, support of execution, and supervision of clinical studies of all types, including: Phase IIIb/IV, registries, real ... with experience in clinical immunology/gastroenterology and/or experience with clinical studies , registries, epidemiology or health outcomes required +… more
- University of Pennsylvania (Philadelphia, PA)
- …more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description Summary With the ... Associate Director for Regulatory Affairs will oversee the portfolio of clinical research undertaken within the department/division. The Associate Director… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- **Job Summary** Under the direction of the Director/ Associate Director of Clinical Management, the Senior Clinical Study Manager is responsible for the ... oversight and management of Otsuka clinical studies , including coordination with other relevant...Contribute to the development and review of all critical clinical study documents, including clinical … more
- University of Pennsylvania (Philadelphia, PA)
- … Research (OCR) in the Perelman School of Medicine and reports directly to the Associate Director, PSOM Office of Clinical Research Compliance. The Clinical ... Perelman School of Medicine and reports directly to the Associate Director, PSOM Office of Clinical Research...study documentation. Conduct training of Investigators, Sponsors and Clinical Research Staff in areas related to clinical… more
- Bristol Myers Squibb (Princeton, NJ)
- …your application should be directed to Chat with Ripley. R1598215 : Associate Director - Incentive Compensation- Field Operations **Company:** Bristol-Myers ... careers.bms.com/working-with-us . **Summary:** Reporting into the Commercialization Strategy & Operations group, the Field Incentive Compensation role plays a… more
- Bristol Myers Squibb (Princeton, NJ)
- …& completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database lock. **Position Summary** The Senior ... BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, ...not limited to: **Project Management and Leadership** + Provides clinical data management leadership within the study … more
- Bristol Myers Squibb (Princeton, NJ)
- …effective risk and issue management. Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback ... TA, where deemed necessary. + Provide quality and compliance consultation to clinical trials teams throughout study lifecycle. + Provide regulatory intelligence… more
- Sumitomo Pharma (Trenton, NJ)
- …relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Catalent Pharma Solutions (Philadelphia, PA)
- ** Clinical Production Specialist** **Position Summary:** + **Work Schedule: 2nd shift, Monday - Friday, 3:45pm - 12:15am.** + **100% on-site** Catalent's ... Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical … more
- Ascendis Pharma (Princeton, NJ)
- …groups. + Work with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations , Compliance, Pharmacovigilance, ... member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and activities… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **Job ... release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. +...escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial… more
- Penn Medicine (Philadelphia, PA)
- …PA Department of Health and keeping current with relevant changes that affect entity operations . The Associate Safety Manager shall be eligible to sit for the ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- University of Pennsylvania (Philadelphia, PA)
- …support the Director of the RVCL Research Center in managing research operations , fostering a collaborative environment for mechanistic studies , therapeutic ... and resources, and much more. Posted Job Title Research Associate Director, D Job Profile Title Associate ...grant and manuscript writing, and coordinating with translational and clinical teams to progress pre- clinical research toward… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **Job ... **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality...process for + OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …and outcomes. + Coordinate GLP-compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies ; oversee assay timelines, critical reagents, data ... focus on Companion Diagnostics (CDx) design control, validation, and clinical enablement, and the agility to pivot to GLP...CLIA/CAP, IVDR, ISO13485, and 21 CFR 11 across lab operations , data, and vendor ecosystems - so we are… more