- Novo Nordisk (Plainsboro, NJ)
- …acquisition, and collaboration opportunities. Evaluate the strength of clinical data , safety profiles, regulatory pathways, and competitive positioning. ... key risks and mitigation strategies for potential assets, considering clinical viability, regulatory challenges, and market access...analytical skills, with the ability to assess scientific and clinical data to identify assets that align… more
- Houston Methodist (Houston, TX)
- …Director to ensure timely communication regarding status of regulatory and/or important safety related issues. + Perform high quality clinical review of ... Operating Procedures (SOPs), and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical … more
- Rush University Medical Center (Chicago, IL)
- …Offers may vary depending on the circumstances of each case. **Summary:** The Clinical Research Regulatory Compliance Manager serves as the subject matter expert ... as well as internal equity and industry specific market data . The pay range for each role reflects Rush's...for a team of Clinical Research Regulatory coordinators within the department… more
- Guthrie (Sayre, PA)
- …JOB DESCRIPTION: Under the direction of the VP, Pharmacy Services, the Pharmacy Clinical Specialist - Regulatory Compliance is responsible for ensuring the ... analysis, planning and implementation of compliance issues + Partners with Quality and Safety , Risk Management, and clinical and administrative staff on an… more
- Houston Methodist (Houston, TX)
- …to ensure compliance and animal welfare. In preparation for IACUC review, the Pre- Clinical Regulatory Analyst gathers additional data as necessary from ... At Houston Methodist, the Office of Research Protections (ORP), Pre- Clinical Regulatory Analyst position is responsible for the comprehensive analysis of… more
- Rochester Regional Health (Rochester, NY)
- …appropriate collaboration among service lines, departments and project teams to enhance patient safety , + clinical excellence and regulatory compliance. + ... Job Title: Registered Nurse, Clinical Regulatory Compliance Department: Physician Practice...referrals to department directors/managers and/or Senior Leaders regarding + regulatory , safety and risk management issues. +… more
- Beth Israel Lahey Health (Boston, MA)
- …and deviations to study protocols. + Oversees reporting of AEs, SAEs, IND safety data , violations, deviations and submission of other study documents to ... in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth...submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety … more
- Ochsner Health (New Orleans, LA)
- …24/7, weekends, etc.). **Job Duties** + Manages research activities associated with clinical trials and data management and facilitates successful study ... today!** This job independently manages and coordinates all aspects of the clinical trials for selected departments and populations according to regulatory … more
- ProMedica Health System (Toledo, OH)
- …acts as a role model and resource to the healthcare team by enhancing safety and quality care. The regulatory specialist assists the team to understand ... with and guides Chapter Chairs, senior and frontline leadership to identify patient safety and regulatory concerns, and initiates action plans with a… more
- Cedars-Sinai (Beverly Hills, CA)
- …or pharmacy regulatory compliance management required. + Possesses excellent clinical data base. + Possesses excellent verbal and written communication ... row on the "Best Hospitals" Honor Roll. As a Pharmacy Manager in Medication Safety & Regulatory Compliance at Cedars-Sinai Medical Center in Los Angeles… more
- University of Miami (Miami, FL)
- …compliance with regulatory reporting requirements, maintaining adverse event data in safety databases, and drafting narratives. Responsibilities include ... collaborating with stakeholders to gather additional safety information, preparing regulatory safety ...new safety databases. + Help in compiling safety data required for Project Status Reports,… more
- Edwards Lifesciences (Irvine, CA)
- …and compliance with regulatory standards + Proficient in building and managing clinical data dashboards, including designing reports and metrics to track key ... expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety...external data management activities to support assigned clinical trials in accordance with regulatory and… more
- Rush University Medical Center (Chicago, IL)
- …of Investigators, Clinical Studies Coordinators, Data Managers, Data Engineers, Data Scientists, Biostatisticians, Regulatory Coordinators, and ... and protocol adherence. In addition, you will aid with the conduct, regulatory support, data collection, and dataset development/maintenance for a variety… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the ... process in partnership with functional compliance teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality… more
- J&J Family of Companies (Santa Clara, CA)
- …sections of clinical study documents. This may also include management of Clinical Events Committee(s) and Data Safety Monitoring Board(s). **Essential ... Management of Clinical Events Committees (CEC) and Data and Safety Monitoring Boards (DSMB) +...medical and regulatory judgement in escalating any safety concerns + In addition, the Principal Clinical… more
- Edwards Lifesciences (Irvine, CA)
- … studies + Full understanding of medical terminology as it relates to clinical safety + Advanced proficiency in Microsoft Office Suite, including Word, ... expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety...safety officers and CEC review in accordance to regulatory requirements, trial safety processes, and EW… more
- University of Miami (Miami, FL)
- …adherence to SOPs, and all applicable regulations and guidelines. CORE JOB FUNCTIONS Extracts clinical data and research data from electronic medical records ... SCCC has an exciting opportunity for a Full Time Clinical Research Data Specialist to work Hybrid...appropriate patient follow up is performed and follow up safety reports are completed and provided to Regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Qualifications** - Must have 4+ years of professional clinical safety expertise from pharmaceutical industry, regulatory agency or academia, with ... as other research areas centered around rare diseases and immune disorders. **Summary** The Director, Clinical Safety , will be a product safety lead or part… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **This position will be supporting early clinical safety for our Rare Disease/Specialty Medicine portfolio.** **Summary** + ... The Director, Clinical Safety , will be a product ... studies, post-marketing surveillance, signal detection and management, important safety topics, and regulatory submissions. + This… more
- Edwards Lifesciences (Irvine, CA)
- …of data collected in clinical studies, the privacy of patient data and efficient recording and reporting of safety related issues. The successful ... expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety...and be part of our inspiring journey. As the ** Clinical Data Management Analyst,** you will translate… more
Related Job Searches:
Clinical,
Clinical Regulatory,
Data,
Regulatory,
Regulatory Safety,
Safety,
Safety Data