- IQVIA (Durham, NC)
- …IQVIA is seeking an experienced Associate Clinical Project Management Director/ Trial Delivery Manager (TDM) to lead and coordinate global and regional ... clinical trial management activities. This role ensures the successful planning,...timely delivery of trial milestones. **Key Responsibilities:** ** Trial Oversight & Management** + Lead the… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …IVRS set-up, central lab set-up, and other vendor selection processes. + Maintaining clinical trial management system (CTMS) information pertaining to the study ... **Knowledge, Skills, and Abilities:** Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs.… more
- ThermoFisher Scientific (Wilmington, NC)
- …management/oversight, including significant study management support experience (eg clinical trial assistant/ associate or lead CRA). Experience could ... Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **CSM ( Clinical Study Manager):** **OBJECTIVES:** ** Lead or support study… more
- Sumitomo Pharma (Raleigh, NC)
- …all relevant ethical, regulatory, and legal standards. + May participate in or lead clinical development contributions to due diligence or other business ... clinical research program with minimal direction + Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing … more
- Gilead Sciences, Inc. (Raleigh, NC)
- …associated capabilities to support the CDS objectives + Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ... help create possible, together. **Job Description** **Job Responsibilities:** + Lead in the development and implementation of quality strategy...ensure clinical trials are conducted in compliance with Gilead procedures,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …As core study/project team member, provide statistical input in different perspective of the clinical trial conduct such as CRF review, IRT setting, DMC set up, ... clinical , statistical, and regulatory literature for current clinical trial results, regulatory trends and new...or other scientific meetings. + Serves as the Biometrics Trial Lead (BTL) in the project team… more
- Parexel (Raleigh, NC)
- …in Lupus is preferred *Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience The ability ... experience treating rheumatology patients clinically and/or who possess extensive rheumatology clinical trial related experience will be considered for this… more
- Parexel (Raleigh, NC)
- … clinical trials. Performs other duties as necessary to ensure optimal clinical trial execution. **Key Accountabilities** **:** **Study Team Support** + ... has an exciting opportunity for a Senior Precision Medicine Associate . This role works closely with line Manager, Precision...collection procedures and presentation slides) + Manages acquisition of clinical trial samples + Provides support for… more
- ThermoFisher Scientific (Greenville, NC)
- …and non-promotional materials to ensure global compliance. + Manages global Clinical Trial Authorization (CTA) submissions and strategy, aligning labeling ... Supply Chain to ensure accurate and timely implementation of labeling decisions. + ** Clinical Trial Regulatory Responsibilities** + Develop and oversee global … more
- Sumitomo Pharma (Raleigh, NC)
- …regulatory submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to ... a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part… more