- ThermoFisher Scientific (Greenville, NC)
- …Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** ** Clinical Affairs , Senior - Study Operations** In this role, ... planning and study execution Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective… more
- United Therapeutics (Research Triangle Park, NC)
- …team and other stakeholders to provide biostatistical resources for investigator-sponsored clinical studies and address internal/external investigator queries of ... input, conduct thorough reviews, and grant approval for submitted investigator-sponsored clinical studies , external investigator queries of UT databases,… more
- United Therapeutics (Research Triangle Park, NC)
- …creative and detail-oriented with deep expertise in regulatory submissions and writing, including clinical study reports, clinical study protocols, and ... manuscripts, posters, and several regulatory documents including but not limited to: clinical study protocols and reports, Investigator's Brochures, and safety… more
- United Therapeutics (Research Triangle Park, NC)
- …successful planning and completion of assigned projects, including clinical studies , registries, or other strategic study /departmental initiatives. + Lead ... for which transplant is not currently an option. The Senior Project Manager of Medical Affairs will...and performance expectations + Serve as primary contact during clinical study /project, including regular collaboration, conferences calls… more
- Sumitomo Pharma (Raleigh, NC)
- …relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Sumitomo Pharma (Raleigh, NC)
- …relationship with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- IQVIA (Durham, NC)
- ** Senior Data Analyst - HEOR** **Job Overview** IQVIA is hiring to expand our dedicated Real World Evidence (RWE) FSP team, working fully within the environment of a ... prominent Pharma company. This senior data analyst role sits within our Real World...development of datasets and conducting HEOR analyses for observational studies in inflammation, virology, and oncology under one client… more
- Parexel (Raleigh, NC)
- …will include ongoing partnership with Client QA and acting as the link between Clinical Development, study teams, global business functions and regional study ... **_Parexel FSP has an exciting opportunity for a Clinical Quality Operations Manager ! This is a...of the quality management system are in place for studies conducted in partnership with non-commercial organizations (eg NGO,… more
- IQVIA (Durham, NC)
- …and Clinical Operations on design of eCRFs. + Contributes to clinical study reports and other regulatory documents eg, DSURs, Briefing Documents, ... **Job Level:** Senior Biostatistician, FSP **Location:** Home-based in the US...study protocols. + Writes the statistical sections of clinical trial protocols, while consulting with internal and external… more
- Edwards Lifesciences (Raleigh, NC)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... summaries of the data to support the development of clinical evaluation reports and clinical study...with 5 years of related experience working in medical affairs , clinical affairs and/or … more
- ThermoFisher Scientific (Greenville, NC)
- …comprehensive patient recruitment strategies with the objectives and timelines of each clinical trial. This involves analyzing study protocols, understanding the ... patient identification to optimize recruitment strategy. Generate regular reports for senior management and study teams providing insights and recommendations… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …that milestones are met. + Support strategy leads by managing the study operational execution of studies including protocol development, vendor selection, ... and other integrated data generation initiatives. This position reports to the Senior Director, Global Integrated Evidence & Innovation Operations and can be based… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- … Clinical Development, Value and Real-World Evidence, Regulatory, Medical Affairs , Data and Analytics, Digital Health and Commercial functions. The successful ... evidence planning and generation. This position reports to the Senior Director, Global Integrated Evidence Strategy and can be...or marketplace dynamics. + Provide expert scientific feedback on study concepts and study protocols in governance… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines, including sample collection, storage conditions, and ... mitigation strategies. + Mentor and train team members on stability study design, execution, and data analysis techniques, fostering their professional growth… more