- Insight Global (Beachwood, OH)
- Job Description - Clinical Strategy & Protocol Development o Lead the development of IRB and clinical study protocols in alignment with company ... case report discrepancies and ensure completeness and integrity of clinical records. o Author or support the development... clinical records. o Author or support the development of clinical study reports, white papers,… more
- Sanofi Group (Cambridge, MA)
- …and Generative AI technologies presents unprecedented opportunities to revolutionize clinical development . As the **Innovation Project Lead in Clinical ... clinical data and analyses **Key Responsibilities** + ** Lead AI Innovation:** Drive the development of cutting-edge AI/ML solutions for clinical data… more
- Boehringer Ingelheim (Ridgefield, CT)
- …with the Medical Affairs Strategy Executive Director to ensure the seamless collaboration with the Clinical Development Lead and the Early Asset TA Lead ... that enable the successful medical affairs contribution to BI's portfolio and informs clinical development efforts where applicable. The incumbent will work with… more
- Sanofi Group (Morristown, NJ)
- …in artificial intelligence (AI) and Generative AI offers enormous opportunities to transform clinical development . The Innovation Project Lead (IPL) in CDAIP ... **Job title:** Innovation Project Lead , Clinical Data AI Processing **Location:**...drive AI-driven solutions to enhance operational effectiveness and accelerate clinical development by enabling real time, interactive… more
- Astellas Pharma (Northbrook, IL)
- …making. + Serves on the clinical sub-team with Clinical lead , Operations Lead , and Medical Monitor/ Development Physician; supports preparation of ... disease area, or clinical development plans. + Partners with Clinical lead in preparing for Health Authority (HA) Meetings and assists in addressing HA… more
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- …of trials leading to NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy and execution for assigned ... requirements, and internal processes. + Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical … more
- BeOne Medicines (Emeryville, CA)
- …actively manage the external messages for the analyst community in collaboration with clinical development lead . + Collaborates with Business Development ... (LCM), in alignment with disease area and portfolio strategy. Lead the Global Product Team (GPT), a cross-functional team...asset across its entire life cycle - from early clinical development to late-stage pivotal studies, then… more
- CSL Behring (King Of Prussia, PA)
- …of ICH guidelines/GCP and its applicability to all stages of the clinical development process Competencies + Demonstrated ability to lead teams and work in a ... meaningful difference worldwide. The **Director Clinical Operations Lead ** is accountable for the development of the operational strategy for a clinical … more
- CSL Behring (King Of Prussia, PA)
- …ICH guidelines/GCP and its applicability to all stages of the clinical development process **Competencies:** + Demonstrated ability to lead teams and work in ... difference worldwide. The Associate Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical … more
- Sanofi Group (Morristown, NJ)
- …and Study Team with study start-up, site opening, enrolment monitoring and supporting. Team development : + Support CRDs, Clinical Lead and Global Project ... report in compliance with quality and regulatory processes. Strategic clinical development plans: + Contributes to preparation...of the study risk management plan. + Support the Clinical Lead and CRD to prepare presentations… more
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