Associate, Study Management III/CTM III

该职位来源于猎聘

• Supporting the Study Project Manager in strategic leadership of the cross-functional team through stakeholder engagement and influence to drive deliverables and timelines including study-level oversight and leadership of assigned activities within one or more global trials in a cross-functional environment for activities from inception through closure.
• Vendor management, from initiation through closure, including deliverable oversight, and risk management for one or more vendors.
• Recruitment management, from country feasibility through subject recruitment and retention.
• Leadership of assigned meetings and training (internal and external) and provision of regular updates on study status, e.g., agenda and minutes.
• Ensure inspection readiness and participate in related activities.
• Risk identification, mitigation, and management.
• Co-development and management of study materials and systems throughout study life cycle (e.g., Protocols, informed consent, clinical study report, training materials, newsletters, presentations, IP, CTMS, eTMF, EDC, IRT, ePRO, access management, etc.)
• Provide engaging training to identified stakeholders as needed.
• Support process improvement initiatives.
• Bachelor’s Degree or OUS equivalent required
• Must have at least 4 years of progressive Pharma-related/clinical research-related experience with a high level of core and technical competencies
• Competent in application of standard quality procedures (SOP, ICH/GCP, Global Regulations)
• Experienced user of systems such as EDC, IRT, CTMS, and eTMF
• Strong analytical and critical thinking skills to evaluate complex issues to support smart decision making and enable a well-run study
• Excellent organizational and time management skills, strong attention to detail
• Exceptional interpersonal skills with ability to communicate effectively in a clear and persuasive manner in a global setting; proficient in business/technical English-language (oral and written)
• Proactive, collaborative mindset
• Ability to work independently in a fast-paced global team environment
• Preferred: Exposure to study initiation through completion activities; global study exposure