Remote · United States
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Chatswood West, Australia
Remote · Australia
$143K–$193K/yr
Published by the employer
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regional Clinical Study Management based in the United States.
This is a strategic clinical operations leadership role overseeing regional delivery of clinical studies and portfolios across the full study lifecycle.
You will lead regional clinical operations teams and external partners while serving as a key escalation point for complex operational issues.
The role combines strategic planning, study execution, quality oversight, resource management, and cross-functional leadership.
You will help shape feasibility, country and site selection, recruitment, regulatory submissions, data collection, and study closeout activities.
A strong focus on inspection readiness, ICH/GCP compliance, operational excellence, and risk management will be central to your impact.
You will collaborate closely with global study teams, country leadership, vendors, medical affairs, regulatory teams, and senior management.
This remote U.S.-based opportunity is suited to an experienced clinical operations leader who thrives in a fast-paced, international, and highly collaborative environment.
Lead regional clinical operations for assigned studies or portfolios, establishing clear goals, driving effective decision-making, and resolving escalated issues.
Oversee regional study delivery from feasibility and startup through recruitment, execution, data collection, and closeout, ensuring alignment with global timelines and priorities.
Drive regional feasibility, country allocation, site selection, startup planning, recruitment timelines, regulatory submissions, and local adaptation of study documentation.
Coordinate internal clinical teams, cross-functional stakeholders, and external vendors, providing regular study updates and escalating risks appropriately to global leadership.
Monitor regional study performance and ensure compliance with protocols, SOPs, ICH/GCP requirements, applicable regulations, and inspection-readiness standards.
Identify operational risks and quality concerns, implement corrective solutions, and prepare sites and teams for audits and regulatory inspections.
Guide CRA coaching and mentoring, support monitoring quality, and ensure appropriate creation, maintenance, and quality control of Trial Master File documentation.
Support clinical data collection, data entry, query resolution, clinical supplies planning, comparator drug considerations, and Clinical Study Report activities as required.
Select and manage regional vendors, negotiate and monitor regional study budgets, oversee resource utilization, and coordinate investigator fees, site payments, and patient reimbursement activities.
Develop and improve regional processes, tools, work instructions, and SOPs while promoting best practices, operational efficiency, and cross-functional knowledge sharing.
Mentor junior team members, delegate responsibilities effectively, support development plans, and build a high-performing clinical operations culture.
Travel as needed to support business and study requirements.
Bachelor’s degree in a scientific or healthcare discipline with 8+ years of progressive clinical operations experience in the biotechnology, pharmaceutical, or CRO industry; alternatively, a preferred master’s degree with 6+ years of relevant experience.
Proven leadership and management experience as a direct people manager or cross-functional clinical study leader.
Strong experience managing regional clinical studies or portfolios across planning, startup, recruitment, execution, quality, and closeout.
Demonstrated knowledge of clinical research operations, ICH/GCP, regulatory requirements, inspection readiness, study quality, and risk management.
Experience managing external vendors, regional budgets, resources, investigator/site payments, and other operational components of clinical studies.
Strong ability to lead cross-functional teams, influence stakeholders, make sound decisions, and resolve complex operational challenges independently.
Excellent written and verbal communication skills, with the ability to provide clear updates and influence stakeholders at multiple organizational levels.
Strong organizational skills and the ability to manage multiple priorities effectively in a fast-paced environment.
Proficiency with Microsoft Office and project planning applications.
Demonstrated analytical thinking, data analysis, initiative, continuous learning, adaptability, and results orientation.
A collaborative leadership style with strong interpersonal skills and the ability to foster teamwork, provide actionable feedback, and develop others.
Ability to operate with an entrepreneurial mindset, exercise sound judgment, and communicate clearly across global and regional teams.
Competitive annual base salary of $143,300–$193,300, with final compensation based on experience, skills, education, certifications, and work location.
Eligibility for an annual bonus plan for non-commercial roles.
Eligibility for discretionary equity awards and participation in an employee stock purchase plan.
Medical, dental, and vision insurance.
401(k) retirement plan.
Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
Life insurance coverage.
Paid time off.
Wellness benefits and programs.
Remote work opportunity within the United States.
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