- Novo Nordisk (Lexington, MA)
- …Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety , Data Management, and Non- clinical ... manage preparation of the written deliverables that support the clinical development and regulatory requirements of a...department + General Tasks: + Interprets and accurately presents clinical and statistical data in a clear,… more
- Houston Methodist (Houston, TX)
- …and institutional policies. In preparation for IACUC review, the Pre- Clinical Regulatory Analyst will gather additional data as necessary from researchers, ... At Houston Methodist, the Office of Research Protections (ORP), Pre- Clinical Regulatory Analyst position is responsible for the comprehensive analysis of… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …associated rulemaking processes. + Strong knowledge of quality measurements, health care policy, clinical regulatory compliance, and patient safety + Strong ... Quality Assurance and Regulatory Compliance, the Director, Clinical Regulatory Compliance is responsible for the...with staff in all divisions of Quality and Patient Safety , as well as with both clinical … more
- Rush University Medical Center (Chicago, IL)
- …depending on the circumstances of each case. **Summary:** This positions provides regulatory support for multiple clinical research studies, which may involve ... analysis documents. * Maintains accurate records related to the regulatory aspects of clinical research. * May... research. * May coordinate timely investigator assessment of safety reports. * Proactively identifies regulatory 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
- Nuvance Health (Danbury, CT)
- *Description* * Clinical Research Regulatory and Operations Coordinator Investigator* *Full-time, 40 hours, Monday - Friday, 8:30 am - 5:00 pm* *Summary:* Reports ... to the Institutional Review Board (IRB) Performs additional non- clinical clinical research coordinator duties (eg data collection, obtaining informed… 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
- AdventHealth (Altamonte Springs, FL)
- …you bring to the team:** . Support AH facilities and AH-IT to maintain timely regulatory measure collection and data transfer to CMS, Joint Commission and other ... AH for reporting or sent to outside vendors or regulatory agencies . Performs data analysis in...department and the AH facilities. . Maintain familiarity with clinical issues and events affecting department . Provide department… more
- Pennsylvania State University (Hershey, PA)
- …. JOB DESCRIPTION AND POSITION REQUIREMENTS: The Pediatric Clinical Research Office at the Penn State College of ... Medicine, Hershey, PA, is hiring a full-time Clinical Research Coordinator. The position supports clinical ...investigator-initiated studies. This position will also take part in data collection, data entry into appropriate databases,… more
- Gilead Sciences, Inc. (Foster City, CA)
- …collaborate with patient safety , quality, regulatory CMC, commercial, clinical , and other development organizations on data governance activities that ... working within the organization. This role ensures compliance with global regulatory data requirements, drives data quality initiatives, and facilitates… 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
- HonorHealth (Scottsdale, AZ)
- …reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding. Assists with subject follow-up for clinical protocols. Works ... communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary Position provides clinical data support for the conduct of clinical … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …aspirations. Join Kite and help create more tomorrows. **Job Description** The Senior Director, Clinical Data Management will report to the ED, Clinical ... projects + Responsible for managing a highly effective team of Managers and Clinical Data Associates supporting highly complex clinical data… more
- University of Rochester (Rochester, NY)
- … reporting. **RESPONSIBILITIES** + Under the guidance of the senior team members, extracts clinical data and research data from electronic medical records ... expertise of the individual, and internal equity considerations._ **Responsibilities:** The Clinical Research Data Specialist I assists in creating, updating,… more
- J&J Family of Companies (San Diego County, CA)
- …+ Experience with data driven hypothesis-testing approaches aimed at resolving pre- clinical or clinical issues of safety concern strongly preferred. ... Johnson & Johnson is recruiting for a Distinguished Scientist, Clinical Pathology& Safety Biomarkers located in Spring...nonclinical studies to ensure generation of timely and high-quality data to inform robust safety assessments. +… more
- Pfizer (Collegeville, PA)
- …You Will Achieve** It is our mission to strengthen the oversight of our clinical data through stronger ownership, control, and visibility. You will play an ... important role in processing, reviewing and receiving clinical data and records and from therapeutic...Practices + Thorough understanding of the processes associated with clinical study management and regulatory operations +… more
- General Dynamics Information Technology (MD)
- …for regulatory , clinical , non- clinical , manufacturing, data management, biostatistics, product technical, safety monitoring.** **The Clinical ... **Job Description:** **GDIT's Military Health team is hiring a Clinical Safety Coder - MedDRA/WHODrug to support...versions per DMP.** **Create project-specific eCRF guidelines for capturing safety data and train sites for each… more
- Edwards Lifesciences (Boise, ID)
- **Senior Specialist, Clinical Safety (THV)** Patients are at the heart of everything we do. As part of our Clinical Affairs team, you'll foster internal and ... part of our inspiring journey. As a Senior Specialist, Clinical Safety in the THV business unit,... officers review and CEC review in accordance to regulatory requirements, trial safety processes, and EW… more
- Edwards Lifesciences (Los Angeles, CA)
- …recording and reporting of safety -related issues. As well as conduct all clinical data management functions (lead clinical study set-up, migrations, ... expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety...be part of our inspiring journey. As the **Senior Clinical Data Manager** , you will ensure… more
- System One (Basking Ridge, NJ)
- Director Clinical Safety 12 month contract Hourly Pay Max: $100- $120 (dependent on experience) Fully remote Description: The Director, Clinical Safety , ... specific areas of safety surveillance and risk management, and provide safety leadership including but not limited to clinical studies, post-marketing… more
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