- Dignity Health (Phoenix, AZ)
- …of our community we are proud_ _to be_ _a tobacco-free campus._ **Responsibilities** The Clinical Research Regulatory Project Manager position exists to ... skill-set with high attention to detail and subject matter expertise in Clinical Research Regulatory Affairs management is essential to drive effectiveness,… more
- Dignity Health (Phoenix, AZ)
- …tobacco-free campus._ **Responsibilities** Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program ... trial sponsors. Responsibilities Include: + Manages all functions of the Clinical Research Regulatory Affairs team with minimal input and supervision from… more
- Cardinal Health (Phoenix, AZ)
- …role involves providing strategic regulatory support across the lifecycle of clinical research , development of clinical development plans, development of ... + Manage and ensure timely submission of regulatory , and clinical documents to meet project timelines and milestones. + Maintain regulatory filings and… more
- Banner Health (Sun City, AZ)
- …QUALIFICATIONS Master's Degree or advanced certificate degrees preferred. Possession of Clinical Research Coordinator Certification (CRCC). Regulatory ... regulatory agencies, and involved institutional departments. Reads and evaluates clinical research protocols. Attends departmental, committee, and sponsor… more
- ThermoFisher Scientific (Phoenix, AZ)
- … trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, ... in the future. Our global Clinical Operations colleagues within our PPD(R) clinical research services provide end-to-end support for clinical trials from… more
- Takeda Pharmaceuticals (Phoenix, AZ)
- …Startup & Engagement in the following departments: **Diversity, Equity & Inclusion in Clinical Research ** + Support the development of a global diversity ... Interns will have the opportunity to partner with the others business units ( Clinical Operations, Regulatory , Legal, Field Medical, R&D Health Equity, etc.) that… more
- Sumitomo Pharma (Phoenix, AZ)
- …review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of in advertising and promotion + ... in line with the global registration strategy of a project in collaboration with the Global Regulatory ...medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in… more
- Sumitomo Pharma (Phoenix, AZ)
- …understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical ... Research & Development Activities + As a Regional Regulatory Lead, manage regional (United States and/or European) ...of the Global Regulatory Team (GRT), leads regulatory activities for assigned project (s) in line… more
- Cardinal Health (Phoenix, AZ)
- …organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role. + Experience writing scientific documents for ... global regulatory programs by incorporating an understanding of the clinical development program, relevant scientific literature, and regulatory goals to… more
- HonorHealth (Phoenix, AZ)
- …Principal Investigators, Clinical Program Leads, Regulatory , Finance, Clinical Trials Personnel, Legal Counsel, and Research Administration. Develop and ... care services, a cancer care network, outpatient surgery centers, clinical research , medical education, a foundation, an...a support role for pipeline, primary start up; and project modification operations within the CTO. This role will… more
- Takeda Pharmaceuticals (Phoenix, AZ)
- …and insights from this internship, including: + Applied Statistical Techniques in Clinical Research : Exposure to real-world applications of advanced statistical ... into Regulatory and Compliance Standards: An understanding of how regulatory guidelines shape statistical analyses in clinical trials, particularly how… more
- Caris Life Sciences (Phoenix, AZ)
- …Position requires 3-5 years of experience in data collection activities within a GCP/ clinical research regulatory environment. + Knowledgeable in critical ... forms and other information related to data collection for clinical research . Must respond to queries in...understanding. + Experience in both small and large scale project planning and reporting with strong communication and presentation… more
- Edwards Lifesciences (Phoenix, AZ)
- … questions and unmet needs preferred **Additional Skills:** + Proven successful clinical project management skills + Expert understanding of relevant US ... Unit strategic initiatives. + Evaluate and identify competitive outcomes research programs to understand clinical strategies. +...and upper management + Ability to consult in a project setting within multiple clinical affairs areas,… more
- Teleflex (Phoenix, AZ)
- … clinical expertise, insight and support to clinical end-users, clinical sales specialist, sales team, Regulatory , Engineering, marketing and other ... Specialists, and Teleflex team members. + Participate as a clinical expert on project teams, committees and...Powerpoint, etc. + Pro-active and results oriented + Strong research , logic and reasoning ability + Clinical … more
- Takeda Pharmaceuticals (Phoenix, AZ)
- …area is advantageous. + Knowledge in global regulatory and compliance requirements for clinical research , including but not limited to US CFR, EU CTD, and ... "inspection ready" at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections....5 or more years' experience in pharmaceutical industry and/or clinical research organization, including 3 or more… more
- IQVIA (Phoenix, AZ)
- …and dedicated sites across various therapeutic areas, offering a proven, turnkey clinical research infrastructure powered by technology and expertise around ... and ethical standards. The ideal candidate will have extensive experience in clinical research area leading large multi-disciplinary teams with a strong general… more
- Takeda Pharmaceuticals (Phoenix, AZ)
- …to processes and tools. Further, CDE efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and ... empower you to shine? Join us as a Senior Clinical Data Engineer in our Cambridge, MA office. At...data collection and extraction processes as well as strong project management and technical experience. The CDE will be… more
- Takeda Pharmaceuticals (Phoenix, AZ)
- … authorities. Further, the DVE team's efforts enable valid secondary use of clinical trial data throughout Takeda research groups to maximize value and ... of your future at Takeda. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office....Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently… more
- Cardinal Health (Phoenix, AZ)
- …biotech industry (preferred). + Ability to prepare, without supervision, any type of clinical regulatory document (eg, protocol, Clinical Study Reports ... to reduce the risk of failure and increase financial returns on your research investments. We provide efficient scientific and regulatory consulting services… more
- Takeda Pharmaceuticals (Phoenix, AZ)
- …the development and execution of integrated evidence generation plans and component research studies (real world evidence and clinical outcomes assessment [COA] ... support evidence needs as defined in the integrated evidence generation plan, clinical development plans and/or regulatory strategies including, but not limited… more