- CSL Behring (King Of Prussia, PA)
- **The Opportunity** The Clinical Trial Supply (CTS) Senior Study Manager manages the end-to-end supply chain for assigned clinical studies ... The CTS Senior Study Manager independently leads clinical studies to ensure compliant, supply of...to clinical sites and patients. + Develop clinical trial supply documents and… more
- J&J Family of Companies (Raritan, NJ)
- …& Johnson, we all belong. This role is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or ... Johnson and Johnson is currently seeking an Senior Local Trial Manager. This position...trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures… more
- IQVIA (Bridgewater, NJ)
- The Associate Clinical Project Manager/Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies to meet ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...activities to bring revenue forward in partnership with the senior project leader. + Identify changes in scope and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and inspections. + Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF). + Keeps abreast of ... Gilead and help create possible, together. **Job Description** **Manager, Global Clinical Supply Chain** **KEY RESPONSIBILITIES:** Manager, Global Clinical… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Manages activities related to IMP shelf-life extensions. + Creates and maintains study specific Clinical Supply trial master files. + Ensures budget control ... evidence, and creating hope for all facing illness. The Senior Manager, Clinical Supplies will manage the... Trial Regulations and agreed Work Orders and Clinical Supply Specifications documents. + Meets with… more
- Merck (Boston, MA)
- **Job Description** The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across ... but are not limited to:** + Participates on the Clinical Trial Team(CTT)and collaborates closely with other...Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics. + Responsible and… more
- United Therapeutics (Research Triangle Park, NC)
- …reports); Oversee database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for sites and/or Contract ... + Demonstrated understanding of the overall drug development process with clinical trial design, study implementation, sponsor/site interactions, scientific and… more
- Teva Pharmaceuticals (West Chester, PA)
- …or oversees the cross-functional clinical development team + Supports Global Clinical Operations in clinical trial initiation, resource planning, study ... Senior Director Clinical Development - Neurology... Senior Director Clinical Development - Neurology Date: Oct 31, 2024...Works with Clinical Supplies Group to ensure clinical drug supply plans and timely procurement… more
- United Therapeutics (Silver Spring, MD)
- …we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of ... role is responsible for the management and execution of clinical quality oversight activities in support of the organization's...team members to provide compliance support in making key trial -related decisions. This is a hybrid position with 3… more
- Bill and Melinda Gates Foundation (Seattle, WA)
- …high-impact in the near term, including leveraging correlates of protection to accelerate clinical development, novel clinical trial designs and AI in ... team's vision is to ensure a secure and sustainable supply of consistently high quality, appropriately priced vaccines that...As a key member of the Vaccine Development team, Senior Program Officer, Clinical Vaccine Development, is… more
- Rush University Medical Center (Chicago, IL)
- …PM) **Summary:** This position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist research staff within the ... and procedures. **Responsibilities:** * Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related guidance documents.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... centered around rare diseases and immune disorders. **Summary** The Senior Director sits within Global Oncology Clinical ...achieve the Target Product Profile (TPP) + Development of clinical sections of trial -level regulatory documents (eg,… more
- Rush University Medical Center (Chicago, IL)
- …Revenue Cycle, this position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist research staff within the ... and procedures. **Responsibilities:** * Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related guidance documents.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …provided by the GDO. + Support flawless implementation and operational aspects of clinical trial execution, data management and data analysis in partnership with ... in large pharmaceutical companies, including a strong background in oncology development and clinical trial design including pediatric programs. + Minimum of 5… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …medicines to patients faster. We are an industry leader for drug development, clinical trial logistics and commercial manufacturing through our Patheon brand. ... phases of development, including API, biologics, viral vector services, formulation, clinical trial solutions, logistics services and commercial manufacturing.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …CSPV and other internal groups) and outside of Daiichi Sankyo (eg clinical trial sites, CROs, collaboration partners); Supports effective direct communication ... Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of...mind in the context of patient management in the clinical trial setting and in the real-world… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address… more
- Penn Medicine (Philadelphia, PA)
- …billing. + Research Related Responsibilities + Interact with individuals/patients associated with clinical trials as well as supply information to patients ... Working for this leading academic medical center means collaboration with top clinical , technical and business professionals across all disciplines. Today at Penn… more
- Catalyst Clinical Research LLC (NC)
- As a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or management ... 7 years previous experience in a Project Manager role in a clinical research setting with a progression of increased responsibility over time. Experienced… more