- 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
- 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
- CSL Behring (King Of Prussia, PA)
- …Work in partnership with Clinical Operations and POE to ensure study assumptions for all studies are up-to-date and reflect accurate assumptions for both ... Opportunity:** Reporting to the Associate Director, Business Operations Management, as the **Manager, Clinical Financial...with close collaboration with POE and Clinical Operations to understand the implications of study … 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
- CSL Behring (King Of Prussia, PA)
- …Authorities where applicable to resolve issues with E2B submission + Review of interventional clinical trial studies and study specific reporting rules: . ... with GSPV Clinical Trial Liason, Risk Management, Clinical Operations and Clinical Research...approval status and update reporting requirements as required. + Study setup of post marketing studies : Review… more
- CSL Behring (King Of Prussia, PA)
- …area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory ... for planning and study execution (member of Study Executive Team, Clinical Development Team) and...study reports and regulatory documents. + Manage outsourcing operations or work with internal statistical programmers within the… 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
- 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
- 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
- IQVIA (Wayne, PA)
- ** Associate Director, Clinical Trial Payments (CTP)...in order to provide high quality outcome for the clinical trial studies that have asked for ... the Pilot as well as post-launch outcomes on a cross- study basis to gain insight and develop future business...years of people management experience required, 10 years of operations experience required (multi-functional desirable) + Clinical … 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
- 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
- Pfizer (Collegeville, PA)
- …groups to ensure study teams are enabled to implement eCOA in clinical studies efficiently, consistently and with the highest quality and lowest regulatory ... integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Senior Associate , eCOA...of the Patient Data Strategies (PDS) team in helping clinical study teams use assigned patient data… 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
- 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
