- 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
- Organon & Co. (Plymouth Meeting, PA)
- …test articles, study records, etc.), and on-site monitoring of non- clinical studies at specific milestones. Additionally, this position will interface ... **Job Description** **The Position** The Non- Clinical Operations Lead within the Non-...Team (NCD), is responsible for operational oversight conduct outsourced non- clinical studies at contract research organizations (CROs),… 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
- 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
- ICON Clinical Research (West Point, PA)
- Senior Clinical Supply Associate - 12 pm to 8...which are vital for the successful execution of our research studies . This is not a remote role. The role is ... clinical development. We are currently seeking a Senior Clinical Supply Associate to join our diverse...external vendors and suppliers to support effective supply chain operations and resolve any issues that arise. **Your Profile:**… more
- Bristol Myers Squibb (Princeton, NJ)
- …+ 5+ years of experience delivering niche technology products in area of Clinical Development (Retrospective Trial Design Intelligence, Digital Study Design, ... our diverse team! As the Product Manager for the Clinical Data Ecosystem within Global Drug Development (GDD) IT...for attracting, nurturing, mentoring, and overseeing the team's daily operations , and collaborating closely with GDD data teams. +… 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
- Merck (West Point, PA)
- …operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s)/ program(s). The incumbent must have ... **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing...ensures proper allocation of drug product as needed across studies within assigned program(s). + Responsible for identifying significant… more
- Merck (West Point, PA)
- … clinical oncology trials, guiding projects from late-stage preclinical work through clinical proof-of-concept studies . + **Translational study design** : ... imaging studies in animal models and early-phase clinical trials (Phase I), ensuring robust study ...scientists, clinical and medical leads, regulatory affairs, clinical operations , and CMC teams. + **Reporting… more
- Parexel (Trenton, NJ)
- … Trial Team (CTT), independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, ... quality/compliance and performance standards. Accountable for vendor service delivery at study level. Collaborates closely with the Vendor Start-up Manager (VSM) for… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …required + Detailed knowledge of S&OP processes + Knowledge of supply chain management operations + Understanding of clinical study packaging and material ... ** Associate Director, Planning** **Position Summary** + **Work Schedule:**...Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and… 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
- Sumitomo Pharma (Trenton, NJ)
- …relationship 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:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical … more
- Parexel (Trenton, NJ)
- …of clinical trial samples + Provides support for sample related matters to clinical study teams + Works with Informed Consent Form (ICF) Specialist and ... clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** ** Study Team Support** +… 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)
- …or follow us on LinkedIn. **Job Duties and Responsibilities** + Lead on clinical studies and manage/provide training to team members when needed. + ... is a global pharmaceutical company based in Japan with operations in the US (Sumitomo Pharma America, Inc.), focused...+ undefined + Experience with integrated summaries (ISE/ISS) and Clinical Study Reports. + Perform other duties… 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