- 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
- Parexel (Raleigh, NC)
- …associated with the set-up, running and close-out of sites in a clinical trial . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is...quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites… 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
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …services in more than 110 countries and regions. The Associate Director of Clinical Operations serves as project lead for clinical studies. Oversees the ... clinical feasibility assessment, strategic planning, and operations of clinical trial programs or studies. Executes on...an equivalency could include 8 years of experience, an Associate 's degree with 6 years of experience, or a… 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
- ThermoFisher Scientific (Wilmington, NC)
- …patient recruitment strategies and the implementation of digital and decentralized clinical trial solutions. + Proven experience providing protocol review ... of Patient-First technology solutions, supporting future innovation and advancing patient-centric clinical trial methodologies. At Thermo Fisher Scientific, we… 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
- IQVIA (Durham, NC)
- …Sharing:** - Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that impact analyses. ... **Job Level: Associate /Director of Biostatistics,** **Rare Disease, FSP** **Location:** **Home-based...regulatory compliance in the application of statistical methodology to clinical trials. Participate as lead statistician on… 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