- 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
- Bristol Myers Squibb (Princeton, NJ)
- …expert on all information regarding the global use of investigational material in clinical studies **Key Responsibilities:** + Provides strategic direction for ... and in their personal lives. Read more: careers.bms.com/working-with-us . The ** Associate Director, Clinical Supply Program Leader** strategizes direction for… more
- Vitalief (New Brunswick, NJ)
- …performance and trial outcomes. + Innovation-Driven: Operate at the intersection of clinical research, financial operations , and advanced technology to transform ... thought leadership forums. Required Qualifications: + 8+ years of experience in clinical research operations , financial management, or related roles. +… 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
- Bristol Myers Squibb (Princeton, NJ)
- …analytics. This is an ideal opportunity for professionals with backgrounds in consulting, clinical operations , or trial analytics who are ready to take ownership ... of delivery and help shape the success of global studies . **Key Responsibilities** + Own study -level analytics...scoring, and performance dashboards + Engage directly with cross-functional study team members ( clinical , feasibility, ops, TA… 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
- 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
- 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
- Bristol Myers Squibb (Princeton, NJ)
- …Ensures compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies , when applicable. Ensures ... + Assists in the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …Office **Job Description** PPD is revolutionizing patient recruitment. As the clinical research division of Thermo Fisher Scientific, PPD has launched Patient ... enabled solutions, Patient First optimizes patient recruitment and engagement, site operations , and quality data collection. Step into a high-impact role where… 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)
- …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
- 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
- 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
- J&J Family of Companies (Spring House, PA)
- …start-up through to database lock and closeout activities as described in Global Clinical Operations (GCO) procedural documents. The Senior Local Trial Manager ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job… more
- J&J Family of Companies (Spring House, PA)
- …teams within Contract & Centralized Services (CCS) and within the broader Global Clinical Operations (GCO) organization to ensure timely, accurate, and compliant ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job… more