- BioAgilytix (Durham, NC)
- …sound product submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory ... life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects… more
- Actalent (Raleigh, NC)
- …services. + Work closely with Clinical Management leadership, Study Project Manager , Clinical Trial Associates, Therapeutic Area leads, Legal, OUS ... a subject matter expert in the development of global clinical trial budgets. The role will frequently...analysis + Familiarity with regulatory requirements and guidelines for clinical trials (eg FDA regulations, ICH GCP… more
- Merck (Raleigh, NC)
- …(including the CTC Clinical Trial Coordinator, CRAs and COM Clinical Operations Manager ). + Responsible for creating and executing a local risk ... Clinical Research Director/CCQM Country Clinical Quality Manager and or CTT Clinical Trial...(as appropriate). + Identifies and shares best practices across clinical trials , countries, clusters. + Responsible for… more
- IQVIA (Durham, NC)
- **Join our team as a Senior Clinical Trial Manager in CVRM!** **A** **pply today and shape the future of healthcare!** We have an opportunity for a Senior ... Clinical Lead (Senior Clinical Trial Manager ) with CVRM (Cardiovascular, Renal & Metabolism) to join our innovative and dynamic group of global… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **Summary:** Manages clinical trial studies for specific therapeutic area(s). Provides guidance and ... Bachelor's degree + Typically requires 5 years experience in clinical research with clinical trials ...role preferably in a pharmaceutical company. Advanced leadership and clinical trial /project management experience in managing study… more
- IQVIA (Durham, NC)
- …Req * Requires understanding of project finances. Req * Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying ... Clinical Leads are an integral part of clinical trial delivery, leading and working alongside...as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials .… more
- IQVIA (Durham, NC)
- …just conducting clinical trials ; we're revolutionizing them. Your role as a Clinical Trial Vendor Manager will be instrumental in ensuring that our ... **Elevate Your Career as a Clinical Trial Vendor Manager !** **About the Role:** Step into a world where your expertise in clinical vendor management… more
- United Therapeutics (Durham, NC)
- …we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials , and we are working to create an unlimited supply of ... sites, vendors, and United Therapeutics staff responsible for conducting clinical trial activities. Compile and report quality... clinical oversight experience as a CRA and/or Clinical Manager in the biopharmaceutical industry +… more
- IQVIA (Durham, NC)
- …obtained through advanced education combined with experience. Req * Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in ... **Job Overview:** Project Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients' lives by bringing new… more
- UNC Health Care (Chapel Hill, NC)
- …infusions, blood product administration, Bone Marrow Transplant patient care, clinical trial administration and monitoring, and urgent care ... care consistent with professional standards. Reporting and accountable to the Nurse Manager /Director, the Clinical Nurse is responsible for coordinating and… more
- IQVIA (Durham, NC)
- … team members; in collaboration with the Study Responsible Physician (SRP). Oversee the Clinical Trial Manager (CTM) in the set[1]up and coordination of ... management of CAPAs). * Accountable for delivery of global trials within agreed/projected life of trial budget....in Life Sciences. * Minimum of 8 years of clinical trial experience in the pharmaceutical industry… more
- ICON Clinical Research (Cary, NC)
- …of specimens. + Performing consult visits as needed. + Completes training on Clinical Trial Management System and maintains proper skills to update database, ... 2025 (40hrs/weekly) **Summary:** The CRC I reports directly to the Clinical Operations Manager , with the primary aim to coordinate multiple studies according to… more
- Merck (Raleigh, NC)
- …team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of ... **Job Description** **Position Description:** **Senior Study Manager - Cardiometabolic** Our Clinical Research...update reports, study closeout activities). May serve as the clinical trial team (CTT) lead. Leads team… more
- Merck (Raleigh, NC)
- …and present technical information effectively. + Good understanding and working knowledge of clinical research, phases of clinical trials , current GCP/ICH & ... and externally. Acts as primary site contact and site manager throughout all phases of a clinical ...continuity of site relationships through all phases of the trial . + Performs clinical study site management/monitoring… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …of all contracts with external providers related to the execution of the company's clinical trials . Interfaces with vendors on all contract and finance related ... to enable high quality and cost-effective services to meet established timelines for clinical trials . Assist in the management of the development of the… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- …for you! Job Duties: As a Senior Clinical Research Associate, you will monitor clinical trial programs and manage regional clinical trial sites to ... Travels up to 80% within an assigned territory, monitors clinical trials according to monitoring plans to...the extended study team including the Sponsor, Vendors, Data Manager (s), Statistician, Medical Monitor and other trial … more
- United Therapeutics (Durham, NC)
- …we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials , and we are working to create an unlimited supply of ... database generation and production of tables and listings; Ensure clinical trial material (CTM) is available for...development experience with hands-on experience managing across Phase 1-4 clinical trials with a master's degree or… more
- ICON Clinical Research (Raleigh, NC)
- …Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment ... efforts. + Completes training on Clinical Trial Management System and maintains proper...needs of the study to the investigators and Site Manager . + Maintaining communication and building relationships with monitors… more
- IQVIA (Durham, NC)
- …accordingly as reflected in SSU systems, milestones and dashboards with Study Leader / Clinical Trial Team (CTT). * Configures and ensures proper trial ... tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS ( Clinical Trial Management System), enrollment plan, vendor management… more
- Edwards Lifesciences (Raleigh, NC)
- …on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to ... Taking charge as statistical lead on one or more clinical trials , lead the coordination of analyses...field, Plus 5 years of previous analytical experience in clinical trial design Required or + Ph.D.… more
