- 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
- 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
- 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
- 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
- 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
- Parexel (Trenton, NJ)
- …Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your ... for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically… more
- Bristol Myers Squibb (Princeton, NJ)
- …to lead structured benefit-risk assessments for assigned assets from early clinical development through late-stage and post-marketing. This role requires close ... relevant departments across the organization, including medical safety assessment, clinical development, global regulatory, epidemiology and others. The SBRA Lead… more
- Bristol Myers Squibb (Princeton, NJ)
- … Overview for Type II variation and coordinate expert reports. + Provide clinical trial expertise for existing evidence generation studies or health-authority ... Read more: careers.bms.com/working-with-us . **Position Summary:** The Established Brands Associate Director, Medical Affairs, is responsible for leading and… more
- GRAIL (Trenton, NJ)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and data science to ... relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations , and other stakeholders to support regulatory strategy development,… more
- Merck (West Point, PA)
- …include research and development, analytical, regulatory, quality, packaging, and operations at our commercialization and commercial supply sites. We recognize ... **Key Responsibilities:** + Plan, conduct, and interpret pharmaceutical process development studies with manager and team support, such as scale up, technology… more