- 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)
- …Manage and facilitate cross-functional study execution teams' efforts towards proactive GCP inspection readiness, focusing on process adherence, TMF ... and empower you to shine? Join us as a Manager , GCP Excellence in Clinical Trials based...+ Provide support in project management, oversight, and expert GCP guidance to study execution teams in Inspection… 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 (Princeton, 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
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager , Clinical Trials.** The Senior Manager , ... operational aspects for clinical studies across Phase 1-4. The Senior Manager , Clinical Trials will work under...trial management and advance knowledge of Good Clinical Practice ( GCP ) and regulatory guidelines are essential in ensuring quality… 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
- 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
- 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
- Evident Scientific (Center Valley, PA)
- …**_Let's inspire healthier lives, together._** We are seeking a detail-oriented and experienced Senior Regulatory Affairs (RA) & Clinical Affairs Manager to join ... business objectives. + Ensure clinical studies comply with Good Clinical Practice ( GCP ), ISO 14155, and other applicable standards. + Lead collaborations with… 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
- US Tech Solutions (Foster City, CA)
- …+ looking for a Vendor Qualification Associate I, who will report to the Senior Manager of Vendor Outsourcing. The candidate will be responsible for ensuring ... vendor capability assessments, sourcing, contracting, procurement, category management, and inspection readiness activities as they will be leading and/or supporting… 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