Clinical Trial Manager
ICON plc
Clinical Research Director
Sanofi
full-time
Posted on:
Location Type: Office
Location: Shanghai • 🇨🇳 China
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud Platform
About the role
- Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps
- Provide medical expertise to the clinical studies and/or registries (eg: protocol, Key Results, Clinical Study Report)
- Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
- Contribute to the Extended synopsis and Protocol for their project
- Contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
- Provide appropriate medical input & support for all activities related to clinical studies such as medical training and feasibility
- Ensure continuous medical review of aggregated data during clinical trial conduct
- Collaborate and communicate appropriately with all function stakeholders to ensure optimal study execution in compliance with Good Clinical Practice (GCP)
- Participate in Advisory Committee preparation
Requirements
- At least 6 years of experience in Clinical Drug Development for a large pharmaceutical or a biopharmaceutical company
- Strong medical background particularly within the therapeutic domain, background in Hematology and Neurology will be preferred
- Excellent understanding of the drug development processes and the regulatory framework for clinical trials
- Strong team player with experience in leading multiple, diverse clinical development programs
- Strong verbal and written communication skills, fluency in English, ability to work transversally
- Ability to interpret clinical data accurately
- Good understanding of biostatistics, pharmacokinetics, regulatory environment (China and Worldwide)
- Ability to analyze and summarize scientific and clinical data and develop recommendations that affect the conduct of studies and the content of regulatory submissions
- Cross-cultural experience in Clinical Drug Development
Benefits
- Health insurance
- Paid time off
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Clinical Drug DevelopmentRegulatory FrameworkBiostatisticsPharmacokineticsClinical Data AnalysisMedical ReviewProtocol DevelopmentSubmission Dossier PreparationGood Clinical Practice (GCP)Clinical Study Report
Soft skills
Team PlayerVerbal CommunicationWritten CommunicationCross-Cultural ExperienceCollaborationLeadershipInterpersonal SkillsAnalytical SkillsSummarization SkillsFeasibility Assessment