Study Management Associate III

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

📋 Description

• Oversee and manage one or more global clinical trials across Phases 0–4.

• Plan, execute, and supervise studies under the direction of the Study Project Manager and SMA Manager.

• Provide leadership and oversight at the study level from initiation to closure.

• Support strategic leadership within cross-functional teams through stakeholder engagement, strategy formulation, meeting facilitation, and documentation.

• Manage external vendors, including the creation of RFPs, selection processes, scopes of work, deliverables, and risk management.

• Lead the management of global recruitment, strategy development, and risk mitigation planning.

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

• Ensure readiness for inspections and participate in related activities.

• Identify, mitigate, and manage risks, including reviewing issues, escalation, and trend analysis.

• Collaborate in developing and managing study materials, protocols, regulatory submissions, patient-reported outcome measures, study execution plans, informed consent documents, budgets and agreements, clinical study reports, training materials, newsletters, and presentations.

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

• Support the design, user acceptance testing, plans, risk indicators, access, query resolution, and oversight for EDC, IRT, and ePRO.

• Manage the investigational product and related study supplies.

• Provide training for 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 equivalent from outside the U.S. is required.

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

• High level of core and technical competencies.

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

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

• Strong analytical and critical thinking abilities.

• Excellent organizational and time management skills.

• Exceptional attention to detail.

• Outstanding interpersonal and communication skills.

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

• Proactive and collaborative mindset.

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

• Preferred experience in study initiation through completion activities.

• Preferred 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.

• Eligibility to participate in short-term incentive programs.