Associate Director, Global Study Management Lead

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

📋 Description

• Oversee the management of Global Study Management Associates (gSMAs) across one or multiple regions, including line management, mentorship, coaching, and career development.

• Allocate qualified gSMA resources to studies in alignment with deliverables and portfolio objectives.

• Monitor compliance with gSMA training requirements.

• Analyze data metrics, CTMS, eTMF, and other reports to pinpoint risks and areas for improvement.

• Ensure the delivery of gSMA tasks meets quality standards for inspection readiness, timelines, and requirements.

• Address and resolve issues related to assigned studies.

• Promote best practices and process enhancements that support studies and teams.

• Lead process optimization and end-to-end improvement initiatives for the PSM team in collaboration with cross-functional stakeholders.

• Work with both internal and external regional and global stakeholders.

• Assist teams in tackling complex issues and influence the gSMA development strategy.

• Anticipate demand, manage workloads, and optimize gSMA resources across studies.

• Conduct interviews, selection, and recruitment of gSMA personnel.

• Manage team onboarding and study transitions.

• Ensure prompt resource allocation and effective planning for the delivery of global clinical studies.

• Set priorities and frameworks for study goals while managing overlapping priorities.

• Implement change management strategies and ensure the consistent adoption of processes, systems, and standards.

• Ensure compliance with ICH Guidelines, Good Clinical Practices, regulatory requirements, SOPs, and work instructions.

• Capture and utilize lessons learned through effective knowledge management.

• Build high-performing teams through recruitment, development, and advancement opportunities.

• Conduct performance evaluations and implement performance management processes for direct reports.

• Guide junior team members and oversee their development plans.

• Contribute to training programs, innovative initiatives, and broader strategic projects.

⛳️ Requirements

• Bachelor's degree or higher in a scientific or healthcare-related field.

• Preferred background in life sciences, such as medicine, nursing, biology, or laboratory technology.

• At least 8 years of experience in the clinical trial sector.

• A minimum of 2 years' experience in a line management role.

• Strong leadership and management experience as a direct line manager or as a cross-functional team leader.

• Proficient in Microsoft Office Suite, including Excel, PowerPoint, and Project.

• Fluent in both written and spoken English.

• Familiarity with ICH Guidelines, Good Clinical Practices, regulatory agency requirements, SOPs, and work instructions.

• Willingness to travel as business needs dictate.

• Exceptions may be considered for candidates with relevant clinical operations experience.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Opportunity for discretionary equity awards.

• Participation in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account.

• Life insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations available during the application process.