- 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
- 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
- Organon & Co. (Plymouth Meeting, PA)
- …to support efficient, on-time execution of clinical studies and early clinical study operations . + Actively facilitate (and escalation as necessary) ... experience in pharmaceutical research and development. + Knowledgeable of clinical operations and study management,...Knowledgeable of clinical operations and study management, and outcomes research studies for… more
- 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
- 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
- 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
- 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
- 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
- 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
- Taiho Oncology (Princeton, NJ)
- …with team members. + Maintain training and oversight to clinical operations /pharmacovigilance vendors supporting pharmacovigilance activities, as needed. ... and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources… 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
- Penn Medicine (Philadelphia, PA)
- …for important clinic operations in assisting with the management of a clinical practice in a busy academic clinical department. Duties are to coordinate ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Penn Medicine (Philadelphia, PA)
- …for important clinic operations in assisting with the management of a clinical practice in a busy academic clinical department. Duties are to coordinate ... this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today...well as supply information to patients enrolled in these studies . * Schedule follow up studies as… more
- Penn Medicine (Philadelphia, PA)
- …for important clinic operations in assisting with the management of a clinical practice in a busy academic clinical department. Duties are to coordinate ... this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today...well as supply information to patients enrolled in these studies . + Schedule follow up studies as… 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
