- 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
- Amicus Therapeutics (Princeton, NJ)
- Senior Associate, Clinical Trial ...Patient enrollment, Monitoring visits, Close out) 10 Manage drug supply at sites 11 Assist with patient tracking to ... ID 2292 # of openings 1 Apply Now (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1338) Senior Associate Clinical Trial Manager… more
- J&J Family of Companies (Raritan, NJ)
- …clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements. The Senior , Local ... Johnson and Johnson is currently seeking a Senior Local Trial Manager, Immunology. This...management role with typically at least 2 years of clinical trial management or 3-5 years of… 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
- J&J Family of Companies (Raritan, NJ)
- …level trial management role. This role is responsible for local management of a clinical trial in a country. The Associate, Local Trial Manager acts as ... trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures...supply , as required. May require guidance from more senior LTMs or FM/CRM. + Prepares country specific informed… 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
- United Therapeutics (NY)
- …responsible for field and off-site monitoring activities for oversight of a clinical trial to facilitate study enrollment; build effective site relationships; ... trials, and we are working to create an unlimited supply of manufactured organs for transplantation. We are the...audits/inspections; provide response for the quality and completeness of clinical trial documentation; may collaborate with the… 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: Nov 29, 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
- Merck (West Point, PA)
- …therapeutic agent into a functional drug product optimized for patients. The Global Clinical Supply organization within PSCS, located in Rahway (NJ), West Point ... a team environment to help solve key challenges in clinical supply chain. + Global Clinical...our company's portfolio to enable the execution of any clinical trial using our company's asset (location:… 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