- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug ... Supply Operations team.As Senior Clinical Drug Supply Manager you will...projects within the area of clinical drug supply management.Oversee inspection readiness and ensure compliance with relevant regulations.Manage operational… more
- BeiGene (San Mateo, CA)
- **_General Description:_** The Senior Manager , GCP Inspection Management is responsible for implementing and maintaining a balanced, proactive, and phase ... deficiencies to senior management, as appropriate + Support and manage GCP Quality investigations + Coordinate and/or administer GCP training, as needed… more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** **Job Title** : Senior Manager , GCP Compliance **Location** : Cambridge, MA **About the ... role:** As a Senior Manager , GCP Compliance, you...inspection risks, providing proactive mitigation directions. + Support GCP inspections and provide guidance to relevant functions and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …company to inspire you and empower you to shine? Join us as a Senior Manager , Integrated Clinical Trial Data Process Excellence and Delivery based remotely ... be a necessary contributor to our inspiring, bold mission. **_GOALS:_** + The Senior Manager , Process Excellence and Delivery supports the strategy to develop… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. ** Senior Manager , Therapeutic Area Quality** **LIVE** **What you will do** Let's do ... Quality Lead - Clinical & Research Quality (CRQ). The Senior Manager , Clinical Quality provides proactive end...in Amgen sponsored trials. **Responsibilities** + Serve as a GCP Subject Matter Expert, providing independent and objective quality… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager of Specialty Laboratory Quality will be responsible ... guidelines as well as Good Laboratory Practice (GLP) and Good Clinical Practice ( GCP ) regulations. They also act as a laboratory quality and compliance subject… more
- Bank of America (Washington, DC)
- Senior Technology Manager - Application Security Chicago, Illinois;Washington, District of Columbia; Denver, Colorado **Job Description:** At Bank of America, we ... Summary** We are seeking a highly skilled and hands-on ** Senior Technology Manager specializing in Application Security**...place to identify, escalate and debate issues. + People Manager & Coach: Provides inspection , coaching and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The ** Senior Manager Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/ GCP . This role applies to internally sourced studies and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …true to the best of my knowledge. **Job Description** Objective / Purpose: The Senior Manager Clinical Data Management is responsible for timely and high quality ... - to ensure they meet obligations as described in ICH- GCP and Takeda's Scope of Work, maximize effectiveness and...Scope of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides and… more
- BeiGene (San Mateo, CA)
- …in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the ... Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues...GCP and all other relevant regulations + Ensures inspection readiness for study in region at any point… more
- HistoWiz (Long Island City, NY)
- …into GLP to support our customers' growing histology needs. Who are you? The Senior Manager /Director of Quality is responsible for overseeing the quality and ... schedule, etc. + Lead internal audits in support of GLP studies, writing inspection reports, following up on observations, ensure timely corrective actions are taken… more
- Amgen (Washington, DC)
- …team. Join us and transform the lives of patients while transforming your career. ** Senior Manager , Quality & Compliance** **LIVE** **What you will do** Let's do ... Clinical Quality, Clinical & Research Quality (CRQ). As the Senior Manager , Quality & Compliance, you will...and effective knowledge management system. + Serve as a GCP Subject Matter Expert, providing independent and objective quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director, Quality R&D Date: Jan 24, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 60470 **Who we are** ... a difference with. **The opportunity** Join Teva as a ** Senior Director of Quality R&D** and lead our quality...all quality activities in R&D, ensuring compliance with GLP, GCP , and CMC standards. + Overseeing Quality Compliance processes… more
- United Therapeutics (Raleigh, NC)
- …protocol, site/UTC Standard Operating Procedures (SOPs), Good Clinical Practice ( GCP ), and applicable regulatory requirements. Trial Support Activities: + Serve ... as the primary contact and site manager with advanced expertise for field monitoring activities to...CRA (iCRA) and study team, as applicable + Perform inspection readiness activities within the eTMF throughout the lifecycle… more
- BeiGene (San Mateo, CA)
- …study sites to ensure data quality and patient safety in accordance with ICH- GCP guidelines, local regulations, and applicable SOPs. The SCRA collaborates with the ... study-specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks… more
- J&J Family of Companies (Raritan, NJ)
- …Associate, Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating ... Procedures (SOP), Good Clinical Practice ( GCP ), and applicable regulations and guidelines from study start-up...process improvement and training. Some supervision from a more Senior , Site Manager ( Senior SM… more
- MicroVention, Inc. (Aliso Viejo, CA)
- …**Title:** Sr. Manager , Clinical Data Management **Job Description:** The Senior Manager , CDM oversees clinical data management activities across multiple ... FDA regulations. Job duties: + Develop and implement SOPs to ensure GCP /ICH compliance for data management, database operations, clinical report writing, case report… more
- Kedplasma (Fort Lee, NJ)
- …**Job Scope / Job Mission** _We are seeking an experienced and highly motivated Senior Clinical Trial Assistant (CTA) to join our Clinical Operations team. This role ... (TMF) maintenance, ensuring completeness and compliance with Good Clinical Practice ( GCP ), SOPs, and regulatory requirements. 3. Perform administrative Trial Master… more
- Access Dubuque (Dubuque, IA)
- …more about you. **How can you make an impact?** We are looking for an experienced Senior Software Engineer to join our Learning Tools teams that is a key part of the ... principles. . Experience with cloud technologies (AWS, Azure, or GCP ). . Familiarity with CI/CD pipelines. . Proven technical...and e2e testing, code coverage analysis and automated software inspection . . Strong sense of customer empathy and a… more
- Mount Sinai Health System (New York, NY)
- …individual will report directly to the Medicine Clinical Trials Office (MCTO Research Manager to assist with the management of the electronic systems most important ... the regulatory affairs team to ensure compliance with FDA regulations, ICH- GCP guidelines, and other relevant local and international regulations for clinical… more
