- Merck & Co. (North Wales, PA)
- …mentorship to other clinical scientist.Core Skills Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability ... the protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with the CRO and the study team. Oversee the site qualification process. Monitor clinical trial performance and quality metrics and share with study ... operations methods and processes in industry setting. requiredExperience considered relevant includes clinical or basic research in a pharmaceutical company, a… more
- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Clinical Research Scientist (CRS) will support and work predominately ... with the Clinical Trial/Indication Lead(s) and Medical Monitor (s) for...will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs,… more
- Merck & Co. (Lower Gwynedd, PA)
- …(eg, neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility ... (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies in which Medical Monitoring activities are conducted by the Contract Research Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO ... with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... least 10 of those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/CRO) A minimum… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term ... Market Access & Public Affairs, Trade, Legal, Compliance, Finance, HEOR, and Market Research . The position has high exposure to senior management and requires a… more
- Merck & Co. (Rahway, NJ)
- …requiring an understanding of biology and high-level scientific concepts and approaches, clinical research and drug discovery and development. Furthermore, this ... within the Corporate Affairs team, closely partnering with our Company's Research Laboratories, Human Health, Animal Health, Manufacturing, Policy, and Investor… more
- Genmab (Plainsboro, NJ)
- …healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory , and other cross functional teams.We ... regional strategies and tactics with appropriate use of resources.Work with clinical development, regulatory , commercial, and market access teams to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brand performance and patient outcomes Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. ... areas. The STARS team collaborates and partners with groups across NAO, Research & Early Development, Development, innovation hubs across NN, other affiliates, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oncology, with a deep understanding of the drug discovery and development process, clinical trials, and regulatory requirements. TravelAbility to travel up to 5% ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryAs a Manager,… more
- Edwards Lifesciences (Chicago, IL)
- …Join us and be part of our inspiring journey. We are searching for a **Senior Clinical Research Monitor ** to join Edwards Aortic Field Monitoring team. As a ... Senior Clinical Research Monitor , you ensure... trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Develop… more
- Dignity Health (Phoenix, AZ)
- …tobacco-free campus._ **Responsibilities** Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program ... clinical trial sponsors. Responsibilities Include: + Manages all functions of the Clinical Research Regulatory Affairs team with minimal input and… more
- Pennsylvania State University (Hershey, PA)
- … Consortium at the Penn State College of Medicine, Hershey, PA, is hiring a full-time Clinical Trial Research Monitor . The Beat Childhood Cancer Research ... (beatcc.org) (https:// research .beatcc.org/) Job Duties & Responsibilities: The Clinical Trial Research Monitor is...background in Clinical Trial Management, Human Subjects Research , and IND/IDE regulatory requirements. It is… more
- Intermountain Health (Murray, UT)
- **Job Description:** This position provides subject matter expertise (SME) regarding regulatory research coordination to Intermountain research departments ... and e-mail and scheduling applications. + Demonstrated years of experience in a research regulatory role. **Preferred Qualifications** + Bachelor's Degree in a … more
- Stanford University (Stanford, CA)
- …Regulatory and Quality Specialist 1 to beResponsible for the administration and regulatory compliance of clinical research within the university. **Duties ... delivering trainings. . Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend… more
- Dana-Farber Cancer Institute (Boston, MA)
- …the design, implementation and evaluation of their program's clinical research activities (therapeutic and non-therapeutic), all related regulatory and ... The CRM is responsible for tracking and complying with clinical trial performance benchmarks; eg protocol and regulatory... trials. + Work collaboratively with clinical research administration and grant managers to help monitor… more
- Mount Sinai Health System (New York, NY)
- …The **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration (CRSC) ... implementing, and overseeing comprehensive training programs for new staff within the clinical research teams. This role ensures that new employees are… more
- Stanford University (Stanford, CA)
- …of patient and research data in appropriate files per institutional and regulatory requirements. + Participate in monitor visits and regulatory audits. ... Cancer Clinical Research Coordinator Associate-Cancer Center South...compliance. **Duties include*:** + Serve as primary contact with research participants, sponsors, and regulatory agencies. +… more
