Global Clinical Study Ops Lead

Parexel; Lansing (MI); On-site; USD 110,000 - 160,000; Full time

Job summary

Parexel is seeking a Country Study Manager in the United States to oversee study-level activities, including trial documents, CRO oversight, and country/regional delivery. You will drive feasibility alignment, target setting, risk reviews, and address country challenges impacting study delivery.

The role requires coordinating with sites, vendors, and internal stakeholders; budgeting, timelines, and training materials; and ensuring inspection readiness. Travel about 10% is expected.

Qualifications

• 5+ years of clinical research experience gained with a CRO, biotech or pharmaceutical company working on phase I-IV global clinical trials.
• 2-3 years leading aspects of global clinical trials.
• Experience working with CROs.

Responsibilities

• Manage integration of project team activities
• Manage strategic study operations including but not limited to study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, budget and financial information, performance metrics, and data flow
• Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specific studies
• Provide input into global subject/patient recruitment plans
• Manage aspects of CRO/vendor identification and the day-to-day operational management activities of CROs and other vendors including set up, statement of work creation, and budget oversight
• Create and update critical trial-specific documents
• Support development of compound and protocol level training materials
• Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
• Provide support for inspection readiness activities including risk identification and mitigation plans at the trial level
• Attend stakeholder meetings and provide input and updates on operational activities and progress

Skills

Decision making

Analytical skills

Financial management

Leadership

Team leadership

Cross-functional collaboration

Mentoring

Organizational skills

Problem solving

Project planning

Communication

Travel readiness

Education

Bachelor's degree

Tools

MS Office

Job description

Parexel is seeking a Country Study Manager in the United States to oversee study-level activities, including trial documents, CRO oversight, and country/regional delivery. You will drive feasibility alignment, target setting, risk reviews, and address country challenges impacting study delivery.

The role requires coordinating with sites, vendors, and internal stakeholders; budgeting, timelines, and training materials; and ensuring inspection readiness. Travel about 10% is expected.