Associate Study Management III

This is a fully remote position, open to applicants in China.

📋 Description

• Oversee and guide one or more global clinical trials at the study level from initiation to completion.

• Assist the Study Project Manager in providing strategic leadership to cross-functional teams, engaging stakeholders, developing strategies, facilitating meetings, managing documentation, deliverables, and timelines.

• Oversee external vendors, including managing RFPs, selection processes, scope of work, deliverable supervision, and risk management.

• Direct global recruitment management, develop strategies, and create mitigation plans from country feasibility to subject recruitment and retention.

• Lead cross-functional, vendor, and investigator meetings; prepare agendas, curate and file minutes, and provide updates on study status.

• Ensure readiness for inspections and participate in related activities.

• Identify, mitigate, escalate, and manage risks and issues; assist with trend analysis and risk prevention efforts.

• Co-develop and manage study materials, which include protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent forms, site budgets and agreements, clinical study reports, training materials, newsletters, and presentations for stakeholders.

• Oversee CTMS and eTMF to ensure compliance, readiness for inspections, trend analysis, and adherence to timelines.

• Support reviews and user acceptance testing for EDC, IRT, and ePRO, along with planning, key risk indicators, access support, query resolution, and system oversight.

• Manage investigational products and associated study supplies.

• Provide training to study team members, vendors, and other stakeholders.

• Assist with global submission strategies.

• Contribute to process improvement initiatives or act as a subject matter expert and/or mentor.

⛳️ Requirements

• Bachelor’s Degree or equivalent qualification outside the U.S. is required.

• A minimum of 4 years of progressive experience in Pharma-related or clinical research roles, demonstrating a high level of core and technical competencies.

• Proficient in the application of standard quality procedures (SOP, ICH/GCP, Global Regulations).

• Experienced in the use of EDC, IRT, CTMS, and eTMF systems.

• Strong analytical and critical thinking abilities to assess complex issues from various angles and formulate strategies.

• Excellent organizational skills and time management, with a keen attention to detail.

• Outstanding interpersonal skills with the capability to communicate effectively in a clear and persuasive manner within a global context.

• Proficient in business and technical English, both oral and written.

• A proactive and collaborative mindset.

• Capacity to work independently in a dynamic global team environment.

• Preferred: experience with activities from study initiation through completion; exposure to global studies.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Supportive work environment that encourages collaboration and innovation.

• Competitive compensation and performance-based incentives.