- 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
- 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
- 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
- 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)
- **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
- IQVIA (Carlsbad, CA)
- …accordance with contracted scope of work and regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH) ... in applying, applicable clinical research regulatory requirements, ie, Good Clinical Practice ( GCP ) and International Conference on Harmonization (ICH)… more
- BeOne Medicines (Emeryville, CA)
- …baseline budget evaluation, change control, study closure budget, budget endorsement by senior management + Adheres to clinical study budgeting processes and ... Description:** + Accountable for global study delivery with appropriate inspection readiness quality , within agreed timelines and budget + Leads all aspects of… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …external data integrations and improve data availability and quality to accelerate clinical data insights and decision making. The Senior Director of ... The Senior Director of Clinical Data Operations...productivity, and regulatory compliance as related to data standards, quality and integrity during data capture, validation and reporting.… more
