Associate, Study Management III

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

📋 Description

• Plan, implement, and oversee one or more Phase 0–4 global clinical trials.

• Offer study-level guidance and leadership from the inception of the trial to its conclusion.

• Assist in the strategic leadership of cross-functional teams through engagement and influence with stakeholders.

• Formulate strategies, lead meetings, and document study-level activities to ensure timely execution.

• Manage external vendors, which includes handling RFPs, selection processes, scopes of work, deliverables, and risk management.

• Direct global recruitment efforts from country feasibility assessments to subject recruitment and retention.

• Conduct cross-functional, vendor, and investigator meetings while providing regular updates on study status.

• Ensure readiness for inspections and engage in related activities.

• Identify, mitigate, escalate, and manage risks associated with the study.

• Collaborate in the development and management of protocols, regulatory submissions, informed consent, budgets, agreements, clinical study reports, training materials, newsletters, and presentations.

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

• Support the design review of EDC, IRT, and ePRO, including user acceptance testing, planning, risk indicators, access, queries, and oversight.

• Manage investigational products and study supplies.

• Provide training to study teams, vendors, and other relevant stakeholders.

• Assist in global submission strategies.

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

⛳️ Requirements

• Bachelor’s Degree or its equivalent from outside the US required.

• Minimum of 4 years of progressive experience in Pharma or clinical research.

• Strong foundation in core and technical competencies.

• Familiarity with standard quality procedures, including SOP, ICH/GCP, and Global Regulations.

• Experience with EDC, IRT, CTMS, and eTMF systems.

• Strong analytical and critical thinking abilities.

• Excellent organizational and time management skills.

• Keen attention to detail.

• Outstanding interpersonal and communication capabilities.

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

• Proactive with a collaborative approach.

• Ability to work independently within a fast-paced global team environment.

• Preferred: experience in study initiation through completion activities and exposure to global studies.

🏝️ Benefits

• Full-time employment.

• Option for remote or virtual work.

• Commitment to equal opportunity employment.

• Reasonable accommodations available for applicants from the US and Puerto Rico.

• Opportunity to contribute to innovative medicines and solutions that address significant health issues.

• Global, cross-functional working environment.

• Opportunities for mentoring and serving as a subject matter expert.