- Eisai, Inc (NJ)
- …provider business relationships in alignment with global strategies.Review and approve Clinical Quality Assurance audit plans and reports.Review and respond ... this is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …negotiations in accordance with all relevant regulations and policies; (Good Clinical Practice ( GCP ), ICH guidelines, federal regulations (Sunshine/Open Payments ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....schedules) Advanced knowledge of regulatory and compliance requirements for clinical research, ICH GCP Principles and the… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Associate Director , Clinical Data Innovation is responsible for overseeing ... an enterprise business intelligence application that utilizes AWS and TableauThe Associate Director , Clinical Data Innovation will lead a team of professionals… more
- Merck & Co. (Rahway, NJ)
- …role is accountable for execution and oversight of local operational clinical trial activities-in compliance with ICH/ GCP and country regulations, ... and-with quality standards internally and externally.Under the oversight of the CRD( Clinical Research Director ) / Director , Clinical Research,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position may propose strategies for external data collections ensuring all clinical & companion diagnostics data meet quality requirements and protocol ... and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data… more
- Eisai, Inc (Nutley, NJ)
- …design and project outcomes.Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.Strong communication and ... statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other...to be a team player, and an advocate for quality , compliance, professionalism, and core corporate values at Eisai.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …difference? The Position Develop role-based training curricula for CMR function to ensure quality and compliance in accordance with ICH/ GCP and other regulatory ... find better and more innovative ways to improve their quality of life. We're changing lives for a living.... clinical research staff Advanced knowledge of Good Clinical Practice ( GCP ), ICH Guidelines, federal and… more
- GE HealthCare (IN)
- **Job Description Summary** The Global Compliance Quality Assurance R&D / GCP Leader is a crucial role within clinical research, particularly in the ... overseeing the quality assurance processes related to clinical trials to ensure compliance with GCP ...related functions. This role reports directly to the Senior Director Global Compliance and Quality Systems Pharmaceutical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Quality is seeking a Senior Director , Inflammation TA Lead to join our Clinical Quality Business Partners Leadership Team. In this role you will lead and ... + Must have broad GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience in a Bio-pharma sponsor organization required.… more
- GRAIL (Durham, NC)
- …(CDx) tests. The Associate Director will work cross-functionally to manage Grail's Clinical Quality Management System; conduct gap assessment and audit of ... (NASDAQ:ILMN). For more information, please visit www.grail.com . Grail's Clinical Quality Assurance (CQA) department is seeking...CFR Part 812 and Part 11]. + Experience managing GCP quality processes such as managing … more
- Bausch Health (Bridgewater, NJ)
- …team members, other Bausch Health departments (eg, Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... of any variances to budget forecast to the Sr. Director or Director of Clinical ...for training purposes. **Qualifications** * Strong knowledge of Good Clinical Practices ( GCP ), clinical trials… more
- e CancerCare (Fresno, CA)
- Purpose: The Director , Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of ... Assures compliance with all regulatory requirements and standards of good practice ( GCP ) related to the conduct of clinical research. Responsibilities/Essential… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution ... studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director (AD)...the investigator follows the approved protocol, training and all GCP procedures and oversees the quality of… more
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Director of Clinical Portfolio Execution? This position is located in our King ... multiple direct reports. You will report to the Senior Director of Clinical Portfolio Execution. **Responsibilities:** **You...process development.** **Knowledge of ICH GCP , FDA GCP Regulations and EU clinical trials directives.**… more
- University of Colorado (Aurora, CO)
- … clinical research leaders to establish standardized processes for performing high quality clinical trials within their functional areas as warranted by the ... Associate Director or Director of Clinical...involved stakeholders. + A strong working knowledge of Good Clinical Practices ( GCP ), US Food and Drug… more
- Intra-Cellular Therapies, Inc (New York, NY)
- … programs, the Director , CTM is accountable for multiple clinical trials, including quality , timelines, and budget. **Responsibilities:** + Accountable ... and results-driven individual to join our company, in the Clinical Operations Department as a Director of...for execution of clinical programs, ensuring that high- quality … more
- ThermoFisher Scientific (Las Vegas, NV)
- …for cancer. Due to continued growth, we are looking to appoint an Associate Medical Director at the Las Vegas Clinical Research Unit. This role is an ... the protocol is being conducted under all applicable laws, regulations and per ICH- GCP guidelines in the organization's Clinical Research Unit (CRU). Consults… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is accountable for the US site CDA/CTA contract negotiations; for ensuring high quality Clinical Trial Investigator budgets are established within fair market ... the Ridgefield, Connecticut office 2-3 times per week. The Director , Clinical Contracting & Budgets will support...is responsible for the execution, delivery and oversight of high- quality clinical trials that meet pipeline commitments,… more
- Hologic (San Diego, CA)
- Senior Director , Clinical Affairs - Diagnostic Solutions San Diego, CA, United States Essential Duties and Responsibilities _This is a full-time San Diego ... with GCP and global regulatory requirements. + Maintains accountability for the clinical effectiveness and overall quality of clinical deliverables. +… more
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