- 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
- 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)
- …& 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
- 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
- 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)
- …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
- 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
- BeOne Medicines (Pennington, NJ)
- …root cause analysis, and risk management. + Experience with tech transfer to clinical /commercial manufacturing facilities. + Knowledge of study design such as ... and authoring of various reports. This position reports directly into the Associate Director, Manufacturing Science and Technology (MST) Cell Culture and is located… more