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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive clinical operations expertise in managing clinical trials, particularly in ophthalmology, while ensuring compliance with regulatory requirements and ICH-GCP guidelines. Proven leadership in mentoring teams, optimizing processes, and maintaining high-quality deliverables in a clinical research environment.
Highest-signal resume keywords
Clinical Operations ManagementLeadership Experience in CRORegulatory Compliance KnowledgeClinical Trial Documentation ExpertiseVeeva Vault eTMF and CTMS Proficiency
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 Trial ManagementRegulatory Guidelines KnowledgeOphthalmology Clinical Trials ExperienceResource ForecastingPerformance Metrics MonitoringSOP DevelopmentOperational OversightProcess ImprovementQuality AssuranceRisk Identification and Management
Soft Skills
Team LeadershipMentoringEffective CommunicationProblem SolvingCollaboration
Tools & Technologies
CTMSETMFVeeva VaultOra ProcessesDIA TMF Reference Model
Industry Keywords
Clinical ResearchClinical MonitoringICH-GCPCROStudy Startup and Closeout
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Serve as the operational lead and subject matter expert for Clinical Trial Associate functions within Clinical Monitoring
- Partner with leadership to implement operational strategies, departmental objectives, and process improvements
- Oversee resource forecasting and workload assessments for the CTA group
- Provide functional leadership, guidance, mentoring, and day-to-day support to CTA staff
- Support CTA onboarding, training, and professional development
- Approve time reporting and expenses for direct reports
- Escalate and resolve CTA operational issues with Monitoring leadership
- Partner with Project Managers, CTMs, and CRAs to align CTA activities with project plans and study timelines
- Monitor CTA performance metrics and operational indicators
- Support inspection readiness and audit preparedness
- Provide operational oversight of CTA deliverables for quality and compliance
- Lead standardization, optimization, automation, and continuous improvement initiatives
- Support development and maintenance of SOPs, work instructions, training materials, and operational tools
- Promote effective use of CTMS, eTMF, and other clinical technologies
- Identify operational risks and recommend solutions
- Oversee CTA support for study startup, maintenance, and closeout
- Ensure study documentation and TMF activities are complete and inspection-ready
- Support compliance with sponsor requirements, SOPs, ICH-GCP guidelines, and regulations
- Occasionally assist study projects requiring additional oversight of junior team members or additional resources
Requirements
What you’ll need- Bachelor’s degree with 5 years’ clinical research experience, or equivalent combination of education, training and experience; years of experience may be considered in lieu of education
- Minimum of 1 year of management or leadership experience, preferably in a CRO setting
- Extensive clinical operations experience in clinical trials, particularly using Ora processes and tools such as Veeva Vault eTMF and CTMS, ICH GCP, DIA TMF Reference Model, and regulatory guidelines/directives is strongly preferred
- Proven ability to lead multifunctional teams and manage and mentor junior clinical operations staff
- Prior CRO experience is strongly preferred
- Ability to motivate and lead or mentor a team and identify and execute coaching opportunities
- Understanding of comprehensive regulatory requirements and implications for clinical operations
- Experience managing external partnerships and relations, including sites, vendors, and sponsors
- Detailed knowledge of regulatory requirements and ICH/GCP guidelines for clinical trial documentation and records management
- Extensive clinical operations experience in ophthalmology clinical trials
- Demonstrated ability to work independently, take initiative, and complete tasks to deadlines
- Ability to communicate effectively with internal teams, sponsors, and external vendors, including issue escalation, training, and responding to inquiries and concerns
- Ability to set goals, create structure, and maintain a focused and collaborative approach to timely, high-quality work
Benefits
Comp & perks- Comprehensive medical, dental, and vision healthcare options beginning day 1
- Flexible PTO
- Unlimited sick time
- 14 company-paid holidays
- 401(k) plan through Fidelity with company match
- Adoption assistance
- Fertility assistance
- 16 weeks paid parental leave
- Company-paid life insurance
- Company-paid disability insurance
- Remote workspace reimbursement
- Wellness reimbursement
- Employee Assistance Program
- Career development opportunities
- Opportunities to work with colleagues across the globe