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Senior Manager, Clinical Operations
PTC Therapeutics, Inc.Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading and managing clinical trial operations, ensuring compliance with ICH-GCP guidelines and global regulations. Capable of developing operational strategies, managing budgets, and mentoring clinical operations staff while maintaining inspection-ready documentation.
Highest-signal resume keywords
Clinical Trial ManagementICH-GCP ComplianceProject ManagementVendor OversightLeadership and Mentoring
About the role
Key responsibilities & impact- Lead or support the operational execution of Phase I-IV clinical trials
- Serve as Lead Clinical Trial Manager for assigned studies, managing study timelines, operational strategy, and deliverables
- Contribute to development planning and operational feasibility assessments
- Develop and manage clinical trial management plans, study timelines, milestone tracking, vendor scopes of work, and operational budgets
- Oversee study start-up, conduct, and close-out activities
- Provide operational oversight of Clinical CROs and other service providers
- Participate in service provider selection, RFP development, and contract review
- Monitor service provider performance, study metrics, and key performance indicators
- Collaborate with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Project Management, Clinical Supply, and Quality Assurance
- Ensure compliance with ICH-GCP, global regulatory requirements, company policies, SOPs, and study protocols
- Support inspection readiness, audit preparation, and follow-up activities
- Identify operational risks and develop mitigation and contingency strategies
- Oversee site identification, feasibility, selection, and activation activities
- Review monitoring reports and study metrics
- Support resolution of site issues, enrollment challenges, and protocol implementation questions
- Contribute to study budget development and financial oversight
- Monitor study progress against timelines, milestones, and performance metrics
- Manage and develop direct reports when applicable
- Mentor, guide, and oversee junior Clinical Operations staff
- Support performance management, professional development, and team training
- Prepare study management plans, service provider oversight documentation, and operational reports
- Provide Clinical Operations Leadership with updates on study status, risks, and mitigation strategies
- Maintain inspection-ready study documentation
- Perform other tasks and assignments as specified by management
Requirements
What you’ll need- Bachelor’s degree in a scientific discipline and a minimum of 7 years of progressively responsible US and/or global experience in clinical research in a pharmaceutical, biotechnology, CRO or related environment OR equivalent education and/or experience
- Strong knowledge of ICH-GCP guidelines and global clinical trial regulations
- Demonstrated ability to lead clinical trial operations and cross-functional teams
- Demonstrated leadership ability and experience managing, coaching and mentoring direct reports (if managing people)
- Strong project management and organizational skills
- Experience with risk-based quality management and vendor oversight models
- Analytical thinking and excellent communication, collaboration, and problem-solving abilities
- Ability to balance strategic oversight with operational execution
- Experience with Microsoft Office Suite
- Experience executing clinical trials in rare disease populations preferred
- Experience working with global centers of excellence and highly specialized investigative sites preferred
- Experience with strategic CRO partnership models and formal service provider oversight documentation preferred
- Working knowledge of risk-based quality management frameworks preferred
- Familiarity with inspection readiness frameworks, trial master file quality expectations, and audit responses preferred
Benefits
Comp & perks- Short- and long-term incentives
- Medical plan
- Dental plan
- Vision plan
- Retirement savings plan
- Approximately 20% travel
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 ExecutionOperational Strategy DevelopmentRisk-Based Quality ManagementBudget DevelopmentStudy Timeline ManagementFeasibility AssessmentPerformance Metrics MonitoringService Provider SelectionAudit PreparationData Analysis
Soft Skills
Analytical ThinkingExcellent CommunicationCollaborationProblem-SolvingOrganizational Skills
Tools & Technologies
Microsoft Office Suite
Industry Keywords
Clinical ResearchPharmaceuticalBiotechnologyCROGlobal Regulatory RequirementsInspection ReadinessTrial Master FileRare Disease TrialsCross-Functional Team LeadershipService Provider Oversight