- Parexel (Honolulu, HI)
- …serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH- GCP compliance issues to Local Management and/or Clinical Quality Management ... monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH- GCP… more
- Parexel (Raleigh, NC)
- …serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH- GCP compliance issues to Local Management and/or Clinical Quality Management ... monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICHGCP, and… more
- Terumo Neuro (Aliso Viejo, CA)
- …including selection, initiation, monitoring, and close-out with strong regulatory and GCP compliance . + Collaborate with Medical Affairs, Clinical Quality ... Management. Ensure high standards of patient safety, data quality, and regulatory compliance while supporting the development and growth of the clinical research… more
- Parexel (Trenton, NJ)
- …to safeguard the quality of investigator sites (eg patient safety, site quality and compliance with GCP ), to maintain investigator and site staff engagement and ... study execution in accordance with applicable prevailing laws, Good Clinical Practices ( GCP ), and sponsor standards. The Sr. CRA is accountable for site management… more
- Caris Life Sciences (Tempe, AZ)
- …Collaborate and communicate with study personnel and stakeholders. + Ensure study protocol, GCP , regulatory and SOP compliance . + Participate in site assessment, ... teams. The Global Companion Diagnostics Specialist will support clinical study compliance through creation and maintenance of trial master files, study tracking… more
- Eisai, Inc (Nutley, NJ)
- …risks. The Senior Director oversees vendor qualification, governance frameworks, and compliance with ICH/ GCP guidelines and local regulations, ensuring ... Collaboration is central, working closely with Finance, Legal, Regulatory & Compliance , IT Security, and Clinical teams to align outsourcing strategies with… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …of study documentation, and assisting with audit and inspection preparation, ensuring compliance with GCP , ICH and company standards. + Other responsibilities ... Data Management and/or the Clinical Project Manager to ensure compliance with specified study protocols. + Oversee the design,...where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core… more
- Terumo Medical Corporation (Somerset, NJ)
- …Plans for studies Conducting audits of clinical sites and eTMF to ensure compliance with ICH- GCP and internal procedures. Track and manage Audit Deficiency ... executing clinical quality oversight activities across Terumo's clinical trials. This role ensures compliance with study protocols, of ISO 14155 / 13485 / 14971, 21… more
- Repligen (Waltham, MA)
- …& ITGC ComplianceWe are seeking an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal controls ... Four experience a plus).Familiarity with cloud security controls (AWS, Azure, GCP ).Strong analytical skills with experience identifying control gaps and developing… more
- BeOne Medicines (Emeryville, CA)
- …**Mid/large pharma experience (preferably clinical operations, process, quality, or compliance roles)** **ICH GCP subject matter expert** **Knowledgeable ... of regulatory requirements (eg, FDA, MHRA/EMA)** **Experience working in a cross-functional, global environment** **Strong written and verbal communication skills** **Deep experience and expertise in end-to-end clinical trial processes including experience in… more
- Seattle Children's (Seattle, WA)
- …Master's Degree in a research or administration field. Demonstrated knowledge of GCP and part 11 validation and compliance . Recognized certification in ... the electronic regulatory binder system, and its maintenance of part 11 compliance . **Required Education and Experience** Bachelor's Degree. Minimum of 5-10 years of… more
- Merck & Co. (Rahway, NJ)
- … Compliance , Ethical Standards, GLP Regulations, Good Clinical Practice ( GCP ), Machine Learning (ML), Marketing, Medical Laboratories, Medical Writing, Multiple ... the candidate be responsible for the conduct of Good Clinical Practice ( GCP ) studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate… more
- HSBC (Austin, TX)
- …Location: Any, TX, US, 78711 Work style: Office Worker Date: 21 Nov 2025 ** GCP DevOps Engineer, HSBC Technology & Services (USA) Inc., Buffalo, NY:** Build and ... manage the HSBC Google Cloud Platform ( GCP ) foundation to enable application deployments. Engineer...agreed base HSBC Hardened OS (Linux and Windows). Ensure compliance with centrally defined Security standards. Ensure compliancy with… more
- Sabre (Dallas, TX)
- …a skilled **Principal Cloud Engineer** with expertise in Google Cloud Platform ( GCP ), Terraform, and Infrastructure as Code (IaC) to design, implement, and manage ... cost-efficiency. **Key Responsibilities:** + Design, deploy, and manage cloud infrastructure on GCP using Terraform and IaC principles. + Build and maintain cloud… more
- Terumo Medical Corporation (Somerset, NJ)
- …the integrity of the SAP and Cloud Security Design and uphold the compliance and regulations setup in the application, database and infrastructure layer. This role ... Segregation of Duties and Critical Access risks to ensure compliance and mitigate security risks. This individual will design...and projects. + Configure and check the SAP and GCP Cloud configuration for Audit log and the retention… more
- Stony Brook University (Stony Brook, NY)
- …including submission of continuations and amendments, as necessary to maintain compliance with NCI requirements, GCP guidelines, and institutional policies. ... Responds to all questions from the IRB related to the regulatory aspects of the study. + Creates and maintains files and documentation pertaining to regulatory requirements for clinical trials. + Obtain consent from research subjects. + Create research records… more
- Eisai, Inc (NJ)
- …strategies that deliver cost efficiencies, enhance vendor performance, and ensure compliance with regulatory and corporate standards. This role manages CRO and ... Proficiency in enterprise systems and a deep understanding of ICH/ GCP guidelines and pharmaceutical operations are essential for success.Essential Functions… more
- Formation Bio (New York, NY)
- …you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good ... Laboratory Practices (GLP), Good Clinical Practices ( GCP ), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities… more
- Insmed Incorporated (NJ)
- …including timelines, budget, data delivery and reporting, vendor management, GCP , etc.Develops operational strategies for implementation of clinical studies ... the development and review of regional/global policies and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.Work with… more
- Merck & Co. (CT)
- …field standard operating procedures (SOPs), Good Clinical Practice ( GCP ) guidelines, and administrative/operational responsibilities Education MD, Ph.D. Pharm.D. ... Diversity and Inclusion (D&I), External Collaboration, Good Clinical Practice ( GCP ), Healthcare Management, Investigator-Initiated Studies (IIS), Leadership, Medical Affairs,… more
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