- Regeneron Pharmaceuticals (Warren, NJ)
- …Study Reports and may support the development of regulatory documents; may perform quality review + Maintains compliance in accordance with FDA, EMEA, ICH ... The Senior Manager , Hematology, Clinical Scientist leads in the development,...skills. Knowledge of clinical development process, regulatory requirements and ICH/ GCP guidelines. Proven track in clinical trial process improvements.… more
- Houston Methodist (Houston, TX)
- …and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices ( GCP ) and all local, state, and ... (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …operational leaders on a regular basis. + Supports PIs and staff to ensure GCP and institutional compliance for all study protocols. + Ensures coordinators are ... winshipcancer.emory.edu. **Winship is seeking qualified candidates for the Assistant Manager , Clinical Trials position.** JOB DESCRIPTION: + Responsible for… more
- Deloitte (New York, NY)
- Are you a process-oriented thinker with experience in international tax compliance ? Do phrases like "best practices," "leading edge technology," and "maximum ... efficiency" pique your interest? Do you enjoy providing international compliance and process improvement advice to US and foreign...International Tax practice. What you'll do As a Tax Manager , you will work within an engagement team and… more
- Cedars-Sinai (Beverly Hills, CA)
- …Faculty and support of Medical Center goals and philosophies. The Manager , Research Operations assumes fiscal responsibility through preparation of unit budgets, ... supports research, participates in both strategic and tactical planning. The Manager , Research Operations is accountable to the Department Chair and/or Institute… more
- Actalent (Gaithersburg, MD)
- …approve study-related plans, manuals, and tools generated by CROs and vendors, ensuring compliance with GCP regulatory requirements. + Participate in the review ... Job Title: Clinical Project Manager Job Description The Clinical Project Manager...vendors, ensuring the successful conduct of clinical trials in compliance with regulatory requirements. The CPM plans, organizes, and… more
- Astellas Pharma (Northbrook, IL)
- …and oversight to ensure completion per established goals and objectives in compliance with applicable GCP /ICH guidelines and other regulatory requirements. This ... **Business Operations Manager - Site Monitoring Strategy Training and Oversight**...scope for this position and may include: + Clinical Compliance + Site Monitoring and Management + Business Operations… more
- Keeper Security, Inc. (El Dorado Hills, CA)
- …AWS, GCP ) and tools such as AWS CLI, AWS KMS, Azure DevOps, and GCP Secret Manager . + Solid understanding of security practices in coding and encryption ... experienced Senior Software Engineer to join our Keeper Secrets Manager (KSM) team. This is a 100% remote position...executing automated tests, enhancing test suites, and ensuring the quality of our web applications. About Keeper Keeper Security… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/ GCP . This role applies to internally sourced studies and studies out-sourced to ... Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of… more
- Bristol Myers Squibb (Indianapolis, IN)
- …for planning, executing, and reporting on internal and external audits to ensure compliance with applicable GxP regulations (GMP, GLP, GCP ), internal procedures, ... ASQ CQA, RQAP- GCP ) is strongly preferred. + Familiarity with electronic quality systems and audit management tools is preferred. + Experience with international… more