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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical research within the pharmaceutical industry, with a strong focus on strategic planning, operational excellence, and compliance with regulatory guidelines. Proven ability to lead teams, optimize processes, and drive data-driven decision-making in complex environments.
Highest-signal resume keywords
Clinical Research ExperienceGCP/ICH Regulatory KnowledgeProject ManagementData AnalysisStrategic Planning
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trials OperationsCRO ManagementData Modelling SoftwareProcess ManagementResource AllocationRisk-Based Decision-MakingTraining and Curriculum DevelopmentDigital ProficiencyPresentation SkillsAccountability
Soft Skills
Strong Communication SkillsCritical ThinkingFlexible/Agile MindsetInfluencePeople Leadership
Tools & Technologies
Microsoft WordMicrosoft ExcelAnalytics SoftwareAutomation-Enabled CapabilitiesAI-Enabled Capabilities
Industry Keywords
Pharmaceutical IndustryClinical DevelopmentPatient-CentricityTrial ExecutionSite PartnershipEnterprise Relationship ManagementMergers and AcquisitionsRegulatory CompliancePerformance MetricsCross-Cultural Awareness
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide vision, leadership, oversight, mentoring and coaching of senior GTO staff in producing GTO deliverables
- Optimize organizational design, resources, key processes, talent and succession management, operating budget, and high-priority programs and studies
- Ensure deliverables meet regulatory, business and patient-centricity standards
- Implement forward-thinking approaches to improve quality and ease of compliance
- Lead data-driven feasibility and recruitment and retention strategies
- Communicate progress, status updates, mitigation plans and escalations to senior management
- Coach and manage the GTO leadership team and ensure quality program/trial feasibility, allocation, recruitment strategies, plans and tactics
- Ensure use of Real World Data in trial execution simulations
- Identify portfolio-level risks and implement mitigation strategies
- Support trial execution through streamlined enterprise-level vendors and standardized digital presence
- Drive compliance with the GCTO Country footprint strategy and evolve processes as business conditions change
- Oversee Trial Engagement and Site Partnership organization and strategies for investigator/site relationships, site experience, screening, enrollment, retention and execution
- Partner with GCTO members on end-to-end clinical trial execution innovations
- Collaborate with CSSM, CQM, Country Operations, GPAM, Clinical Directors, Legal and other stakeholders
- Determine resource needs based on clinical development activities
- Monitor pharmaceutical industry best practices, regulatory requirements and corporate strategies
- Drive continuous improvement and optimize deliverable predictability and accuracy
- Establish and monitor performance metrics
- Lead operational components of mergers and acquisitions when needed
- Lead or implement process improvement and strategic initiatives
Requirements
What you’ll need- Required: Bachelor of Science/Arts; advanced degree preferred
- Minimum of 15 years clinical research experience in pharmaceutical industry (US and exUS)
- Proficiency in written and spoken English
- Strong communication skills, including written and verbal communication and ability to influence and represent the organization at senior regional and global levels
- Digital proficiency with enterprise-level digital, analytics, automation-enabled and approved AI-enabled capabilities
- Risk-based decision-making and leadership
- Critical thinking in complex and ambiguous situations
- Flexible/agile mindset
- Accountability and decision rights within governance frameworks
- Entrepreneurship and deep knowledge of pipeline, patient and investigator landscape, health systems and external environment
- Strategic planning and execution excellence
- Enterprise relationship management and partnerships
- Project Management or Site Ready support knowledge and experience
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Superior presentation skills
- Training and curriculum development
- Computer skills, including data analysis and presentation software, Microsoft Word and Excel
- Preferred: proficiency with data modelling software, process management, international collaboration, Sigma training
- Required skills include Clinical Research Organizations (CRO) Management, Clinical Trials Operations, Cross-Cultural Awareness, Influence, People Leadership, Resource Allocation, Results-Oriented, and Strategic Thinking
- VISA Sponsorship: Yes
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Relocation: Domestic/International
- VISA Sponsorship: Yes
- Hybrid flexible work arrangement
