Global Clinical Study Lead

Advanced Recruiting Partners; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Advanced Recruiting Partners seeks a Senior Clinical Project Manager / Global Study Manager to lead end-to-end global clinical trials. You will oversee CROs and vendors, coordinate cross-functionally with Regulatory, Data Management, Biostatistics, Safety, and CMC teams, and ensure delivery on time, budget, and quality.

The role demands 8+ years in clinical operations, with 5+ years leading global trials, and experience in multi-regional studies across US, Europe, and APAC.

Qualifications

• Bachelor's degree in life sciences or related field required.
• Advanced degree preferred.
• 8+ years of clinical operations experience.
• 5+ years leading global clinical trials.
• Experience overseeing CROs and global vendors.
• Experience in multi-regional studies (US, Europe, APAC) preferred.

Responsibilities

• Lead the planning, execution, and delivery of global clinical trials from study start-up through close-out
• Serve as the primary operational lead for assigned studies, ensuring adherence to timelines, milestones, budgets, and quality standards
• Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Safety, CMC, and other internal teams
• Manage and oversee CROs, vendors, and external partners, including performance oversight, issue resolution, and continuous improvement
• Develop and maintain comprehensive study plans, timelines, risk mitigation strategies, and operational metrics
• Ensure compliance with ICH-GCP, internal SOPs, and applicable global regulatory requirements
• Identify, assess, and proactively manage study risks, operational challenges, and scope changes
• Contribute to protocol development, feasibility assessments, and overall study strategy
• Support inspection readiness activities and participate in audits and regulatory inspections as needed
• Mentor and support junior team members and contribute to operational excellence and process improvement initiatives

Skills

Leadership

Communication

Stakeholder management

Organizational skills

Independent work

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Job description

Advanced Recruiting Partners seeks a Senior Clinical Project Manager / Global Study Manager to lead end-to-end global clinical trials. You will oversee CROs and vendors, coordinate cross-functionally with Regulatory, Data Management, Biostatistics, Safety, and CMC teams, and ensure delivery on time, budget, and quality.

The role demands 8+ years in clinical operations, with 5+ years leading global trials, and experience in multi-regional studies across US, Europe, and APAC.