- Merck & Co. (North Wales, PA)
- …protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and ... and key strategic engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage… more
- Merck & Co. (Rahway, NJ)
- …for clinical supplies . - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address ... analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works...- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices ( GCP ) is highly desirable. -… more
- Merck & Co. (Rahway, NJ)
- … Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and ... deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders. -Responsible and accountable for… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… more
- Eisai, Inc (Nutley, NJ)
- … trials with the utmost compliance and quality consistent with Good Clinical Practice ( GCP ). This individual must effectively balance strategic vision with ... to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role... operations activities. These activities directly impact the timeliness, quality , and successful execution of clinical studies… more
- Genmab (NJ)
- …of our Global Medical Writing team, you will drive the development of high- quality clinical documents to support operational, medical, and regulatory activities ... immunology experience preferredDemonstrated experience authoring protocols, investigator's brochures, and clinical study reports. Senior level candidates should… more
- BeOne Medicines (Emeryville, CA)
- …and Experience: + BA/BS degree required; advanced degree preferred. + GCP Quality Assurance auditor's registration/certification preferred. + Minimum of ... General Description: This position within R&D Quality is a senior Auditor role...GCP auditors (external and internal audits) and relevant clinical trial experience. + Minimum 3 years of direct… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …global clinical regulations and guidance. + Support the development of GCP Audit material/insights for quality forums and management reviews. _Training & ... and with senior leadership, on key projects and deliveries supporting quality and compliance. + Demonstrates ability to execute against the strategic and… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …working in either a quality /compliance role (eg, Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or ... The Associate Director, Global Development Quality Inspection Management (GDQIM) acting as an Inspection...transferable skills related to Good Clinical Practice ( GCP ), and/or Good Pharmacovigilance Practice… more
- Amgen (Washington, DC)
- …this. Let's change the world. In this vital role you will support Amgen-sponsored clinical trials worldwide. Reporting to the Senior Manager of R&D Supplier ... Governance, you will help ensure the quality and integrity of processes and data generated by...in a global, matrix organization. + Knowledge of Good Clinical Practices ( GCP ), FDA regulations and guidelines,… more
- Danaher Corporation (Austin, TX)
- …Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager, Clinical Quality and ... Compliance reporting to the Senior Director of Clinical Compliance will ensure that Danaher Diagnostics Clinical...+ Bachelor's degree in science with 14+ years of clinical quality / GCP experience within the… more
- University of Colorado (Aurora, CO)
- … Research Support Team (CReST) has an opening for a full-time Point to Senior Clinical Research Coordinator to provide regulatory, study coordination, and data ... ** Clinical Research Point Coordinator Open Rank Intermediate to Senior ** **Description** **University of Colorado Anschutz Medical Campus** **Department: … more
- Pfizer (New York, NY)
- …encourages strong partnerships and mutual trust. + Supports the GDL and senior clinical scientist, in developing effective collaborations with project leaders ... **ROLE SUMMARY:** The Senior Manager, Oncology Early Stage Clinical ...FIH programs through proof-of concept and delivering on innovative clinical study designs, high quality trial execution… more
- e CancerCare (Fresno, CA)
- …Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential ... staff, subIs, and PIs complete and maintain appropriate certifications specific to clinical trial participation ( GCP , Conflict of Interest, FDA Focused, and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager, Oncology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... interpretation of study data of a clinical development program. The Senior Manager leads...GCP guidelines as well as applicable SOPs regarding clinical safety + Performs clinical /medical data review,… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …position in one of our office locations. Fully remote is not eligible._ The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of ... for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study...study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study… more
- Teleflex (Wayne, PA)
- Senior Director, Clinical Evidence Generation (REMOTE) **Date:** Jul 23, 2025 **Location:** Wayne, PA, US **Company:** Teleflex **Expected Travel** : Up to 10% ... **Principal Responsibilities** * Oversees design, implementation, and management of clinical studies with responsibility for quality , timeliness...regulations of 21 CFR in particular Part 11, Good Clinical Practice ( GCP ) and ISO 14155 and… more
- University of Colorado (Aurora, CO)
- ** Clinical Science Professional (Open Rank: Entry- Senior )- Emergency Medicine** **Description** **University of Colorado | CU Anschutz Medical Campus** **School ... Research Services Clinical Science Professional (Open Rank)** **Working Title: Clinical Science Professional (Open Rank: Entry- Senior )** **Position #795275 -… more
- University of Colorado (Aurora, CO)
- **Entry- Senior Clinical Research Services Professional (open rank)** **Description** **University of Colorado Anschutz Medical Campus** **Department: ... Ophthalmology** **Job Title: Entry- Senior Clinical Research Services Professional (open rank)**...+ Knowledge and understanding of federal regulations and Good Clinical Practice ( GCP ) + Ability to communicate… more
- University of Colorado (Aurora, CO)
- ** Clinical Research Nurse ( Senior Principal Level)** **Description** **University of Colorado Anschutz Medical Campus** **Department: Emergency Medicine** **Job ... Title: Clinical Research Nurse ( Senior - Principal Level)**...Advanced knowledge and understanding of federal regulations and Good Clinical Practice ( GCP ) + Ability to communicate… more
