Clinical Trial Manager at ICON managing trial operations, ensuring high - quality outcomes and compliance with trial protocols for clinical development in Beijing and Shanghai.
About the role
- Clinical Scientist in cell therapy responsible for design and execution of clinical trials. Collaborating with cross-functional teams and external partners to ensure study success.
Responsibilities
- Responsible for design and execution of assigned clinical trial activities
- Collaborate and liaise with external partners (e.g., KOLs)
- Develop Protocol and ICF documents/amendments and present these to governance committee
- Conduct literature review and submit clinical documents to TMF
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- Monitor clinical data for specific trends
- Ensure CRF design aligns with data collection in collaboration with Data Management/Programming
- Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents
Requirements
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- 5 to 10 years of appropriate alternative experience (new entrance to pharma)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills (develop short range plans that are realistic and effective)
Benefits
- Wide variety of competitive benefits
- Services and programs that provide resources to pursue goals
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Clinical Research Coordinator overseeing research studies at Florida Cancer Specialists. Responsible for implementation and management of clinical trials under medical supervision.
Senior Clinical Trial Manager at Climb Bio leading end - to - end execution of Phase 1 - 3 clinical studies. Critical role in clinical operations and study management with a focus on quality and compliance.
Senior Clinical Researcher collaborating globally to design and evaluate digital health investigations. Engaging in statistical analysis and contributing to product development for cognitive health.
Assistente de Pesquisa Clínica Júnior supporting scientific team for clinical studies and protocol development at MEDCIN Pesquisa Clínica.
Clinical Research Project Coordinator providing research project support across Intermountain system. Responsible for project coordination, communication, and documentation in healthcare research.
Principal Biostatistician Consultant at ClinChoice overseeing drug development statistical methodologies. Lead statistician for clinical studies in a hybrid work environment.
Part - time Clinical Research Coordinator for Penn's Center for Weight and Eating Disorders. Assist in industry - funded study on behavioral treatment effects and weight loss medications.
Clinical Research Coordinator supporting clinical research at University of Wisconsin. Collaborating with investigators and multidisciplinary teams to advance patient - centered research.
Managing clinical research coordinators for data quality and participant management at USF Health. Overseeing daily operations and coordinating with sponsors, ensuring compliance in clinical trials.