- Novo Nordisk (Plainsboro, NJ)
- …budget review and forecasting + Independently manage interactions with clinical monitors, data management, safety , regulatory and QA team members, both ... requirements + Participate in the development and testing of clinical systems (eg, data capture, IxRS) +... study progress and surveillance of key efficacy and safety data points + Collaborate with other… more
- Astrix Technology (GA)
- …Drug Safety , Medical Affairs, Regulatory Affairs, Statistical Programming, Clinical Programing, and Clinical Data Management. + Partner with ... **Business Development Director, Clinical & Regulatory (Remote)** **POSITION** **Reports To:** VP of Scientific Staffing **FLSA Status:** Exempt **ROLE**… 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
- 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
- Hackensack Meridian Health (Edison, NJ)
- …mission to transform healthcare and serve as a leader of positive change. The ** Clinical Data Analyst** is responsible for providing support of the collection, ... organization and integrity of clinical data required for clinical ...and TJC. + Facilitates and collaborates with DTS for data uploads specific to regulatory submission … more
- DRT Strategies, Inc. (Silver Spring, MD)
- …Responsibilities + Prepare, oversee, and maintain project schedules. + Develop safety data review plans (SDRPs) with clinical reviewers in advance of initial ... Provide written reports regarding assessment of safety data sufficiency, integrity, and quality to clinical ...(eg, adequate and well-controlled studies) + Familiarity with FDA regulatory process. + Working experience at FDA. + Experience… more
- HonorHealth (Scottsdale, AZ)
- …communities across Arizona. Learn more at HonorHealth.com. Responsibilities Job Summary Position provides clinical data support for the conduct of clinical ... accordance with FDA Regulations, International Council of Harmonization, and Good Clinical Practices. Provides data management project support for… more
- Pfizer (South San Francisco, CA)
- …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 ... **Power Your Purpose** Pfizer Worldwide Medical and Safety colleagues play a key role in connecting...important role in processing, reviewing and receiving clinical data and records and from therapeutic… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …New England state (ME, VT, NH, MA, CT, RI).** The Clinical Trial Data Manager I performs analytical and regulatory work directly related to DFHCC's policies, ... process improvement. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring,… 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 of our clinical ... data and records. You will be organizing clinical data forms from therapeutic groups and...and Drug Administration & International Conference on Harmonization Good Clinical Practices (GCDMP), and related regulatory requirements… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …research protocols. KEY RESPONSIBILITIES: + Supports and assists in all aspects of clinical data management, protocol data management, including creation and ... clinical trials. This role collaborates with the clinical , informatics, quality monitors, and/or regulatory teams...records and metrics on each research study participant. Consolidates clinical data and reports for investigators as… more
- J&J Family of Companies (Spring House, PA)
- …+ 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 (Groton, CT)
- …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
- 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
- Edwards Lifesciences (Irvine, CA)
- …recording and reporting of safety -related issues. He/she will 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...US **How you will make an impact:** **The Senior Clinical Data Manager - Transcatheter Heart Valve**… 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 ... GENERAL PURPOSE: The Clinical Research Data Specialist I assists...medical records, other available sources). + Under guidance, updates data and safety related information in OnCore… more
- ThermoFisher Scientific (Cambridge, MA)
- …Location/Division Specific Information \#CorEvitas Discover Impactful Work: As part of the Clinical Data Management (CDM) team, the Associate Director of ... treatments to market. Your objectivity and dedication to patient safety will improve health outcomes that people and communities...Clinical Data Management is responsible for managing the … more
- Cedars-Sinai (Beverly Hills, CA)
- …objectives. Responsible for completing case report forms, entering clinical research data , and assist with regulatory submissions to the IRB. Provides ... Administrator or Research Nurse to coordinate/implement study. + Evaluates and abstracts clinical research data from source documents. + Ensures compliance with… more
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