Senior Clinical Trial Manager

SoTalent; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

SoTalent is seeking a Senior Clinical Trial Manager to lead global Phase I–IV trials from planning to closeout. You will oversee study strategy, cross-functional execution, budgets, timelines, vendors, TMF, and regulatory compliance while providing operational leadership across global teams.

The role requires 7+ years in clinical research and experience in global trial management, with strong stakeholder engagement and project management skills.

Qualifications

• 7+ years in clinical research, including global trial management
• At least 3 years in clinical operations leadership
• Proven experience managing global, multi-center trials
• Strong knowledge of ICH-GCP and regulatory requirements
• Experience with study start-up and regulatory planning
• Experience with TMF/CTMS and other systems
• Bachelor’s degree in Life Sciences or related field, or equivalent experience

Responsibilities

• Lead planning, implementation and execution of global Phase I–IV trials.
• Develop trial strategies, timelines, budgets, recruitment and risk plans.
• Coordinate cross-functional study teams and lead trial meetings.
• Oversee external vendors and clinical budgets.
• Manage TMF activities and essential trial documentation.
• Review protocols, informed consent forms and clinical study reports.
• Support feasibility and investigator selection and recruitment strategies.
• Mentor Clinical Research staff and drive issue resolution.

Skills

Stakeholder management

Communication

Influencing

Project management

Organisational skills

Education

Bachelor’s degree in Life Sciences/Healthcare or related field

Tools

CTMS

TMF

Clinical trial management systems

Job description

Senior Clinical Trial Manager – Global Clinical Operations

Location: Philadelphia, PA, US

Employment Type: Full-time

Work Model: Remote

Overview

Senior Clinical Trial Manager responsible for leading global Phase I–IV clinical trials from planning through closeout. The role oversees study strategy, cross-functional execution, vendors, budgets, timelines, documentation, risk management and GCP compliance while providing operational leadership across global clinical teams.

Key Responsibilities

• Lead planning, implementation and execution of global, multi-center Phase I–IV clinical trials.
• Develop trial strategies, timelines, budgets, recruitment plans and risk mitigation plans.
• Coordinate cross-functional study teams and lead trial-related meetings and working groups.
• Provide operational oversight of external service providers and clinical vendors.
• Manage vendor performance, financial spend, timelines and contractual deliverables.
• Oversee Trial Master File (TMF) activities and essential trial documentation.
• Review and approve protocols, informed consent forms, monitoring plans and Clinical Study Reports.
• Support feasibility, study start-up, investigator selection and patient recruitment strategies.
• Lead Investigator Meeting planning and delivery.
• Identify and manage operational risks, issues and contingencies.
• Provide study updates, risks and recommendations to senior leadership.
• Serve as a clinical operations subject matter expert during audits and regulatory inspections.
• Ensure trial activities comply with ICH-GCP, SOPs, regulatory requirements and study protocols.
• Coordinate clinical supplies and investigational medicinal product shipment activities.
• Support monitoring report review, data query processes and trial management systems.
• Contribute to Clinical Operations and Global Clinical Development Operations initiatives.
• Mentor and coach Clinical Research Associates, Global Study Managers and Global Study Associates.
• Lead high-performing clinical trial teams and support resolution of complex study issues.

Requirements

• 7+ years of clinical research experience, including global clinical trial management.
• At least 3 years in clinical operations leadership.
• Proven experience managing global, multi-center clinical trials.
• Strong knowledge of clinical trial processes, ICH-GCP and regulatory requirements.
• Experience with study start-up and regulatory planning.
• Experience with CTMS, TMF and other clinical trial management systems.
• Excellent project management and organisational skills.
• Strong stakeholder management, communication and influencing skills.
• Bachelor’s degree in Life Sciences, Healthcare or related field, or equivalent experience.