Associate, Study Management III

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

📋 Description

• Plan, implement, and oversee one or more global clinical trials spanning Phase 0–4 from start to finish.

• Offer study-level guidance and leadership within a cross-functional global framework.

• Assist in strategic leadership through engagement with stakeholders, development of strategies, facilitation of meetings, and documentation.

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

• Direct the global recruitment strategy, feasibility assessments, subject recruitment, retention efforts, and planning for risk mitigation.

• Conduct cross-functional meetings with vendors and investigators, providing regular updates on study status.

• Ensure readiness for inspections and participate in related activities.

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

• Co-develop and manage study materials such as protocols, regulatory submissions, informed consent documents, budgets, agreements, clinical study reports, training materials, newsletters, and presentations.

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

• Support design reviews, user acceptance testing, plans, risk indicators, access, queries, and system oversight for EDC, IRT, and ePRO.

• Manage the investigational product and related study supplies.

• Provide training to members of the study team and vendors.

• Assist with global submission strategies.

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

⛳️ Requirements

• Bachelor's Degree or equivalent international qualification is required.

• A minimum of 4 years of progressive experience in pharmaceutical-related or clinical research roles.

• High proficiency in core and technical competencies.

• Familiarity with standard quality procedures, including SOPs, 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, coupled with a keen attention to detail.

• Outstanding interpersonal and communication skills in a global context.

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

• A proactive and collaborative mindset.

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

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

🏝️ Benefits

• Paid time off (including vacation, holidays, and sick leave).

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option for virtual/remote work.