Associate, Study Management II

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

📋 Description

• Contribute to the planning, execution, and oversight of one or more Phase 0–4 global clinical trials.

• Assist the Study Project Manager and cross-functional team with stakeholder engagement, meeting facilitation, documentation, deliverables, and timelines.

• Oversee external vendors, including RFPs, vendor selection, scopes of work, deliverables, and risk management.

• Manage recruitment strategies and mitigation planning from country feasibility through subject recruitment and retention.

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

• Ensure inspection readiness and participate in related activities.

• Identify, mitigate, escalate, and manage study-related risks.

• Co-develop and manage protocols, regulatory submissions, study execution plans, informed consent forms, site budgets and agreements, clinical study reports, training materials, newsletters, and presentations.

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

• Support EDC, IRT, and ePRO design reviews, user acceptance testing, plans, risk indicators, access support, query resolution, and system oversight.

• Manage investigational products and associated study supplies.

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

• Support process improvement initiatives or serve as a subject matter expert or mentor.

⛳️ Requirements

• Bachelor's Degree or equivalent from outside the U.S. is required.

• A minimum of 2 years of experience in pharma/device or clinical research is necessary.

• Proficiency in standard quality procedures, SOPs, ICH/GCP, and Global Regulations.

• Strong analytical and critical thinking abilities.

• Excellent organizational and time management skills.

• Exceptional attention to detail.

• Strong interpersonal and persuasive communication skills.

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

• A proactive and collaborative mindset.

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

• Preferred: experience with one or more clinical trial systems, such as EDC, IRT, CTMS, or eTMF.

• Preferred: experience in one or more components of a clinical trial.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Option for remote/virtual work.

• Equal opportunity employer; support for veterans and disabled applicants.