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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 expertise in leading and managing clinical trial operations, including oversight of study timelines, vendor management, and compliance with ICH-GCP guidelines. Proven ability to mentor teams, develop operational strategies, and ensure inspection readiness throughout the clinical trial process.
Highest-signal resume keywords
Clinical Trial ManagementICH-GCP GuidelinesProject ManagementVendor OversightRisk-Based Quality Management
About the role
Key responsibilities & impact- Lead or support 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 alignment of operational study and program strategy and development timelines
- Support inspection readiness, audit preparations, 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
- Implement corrective actions as needed
- 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 study status, risk, and mitigation updates to Clinical Operations Leadership
- Maintain study documentation in an inspection-ready state
- Perform other tasks and assignments as needed and 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
- Ability to lead clinical trial operations and cross-functional teams
- 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
- Passion in advancing therapies for patients with unmet medical need
- 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 opportunity
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 DevelopmentStudy Budget DevelopmentMilestone TrackingSite Selection and ActivationPerformance Metrics MonitoringAnalytical ThinkingProblem-SolvingInspection ReadinessTrial Master File Management
Soft Skills
LeadershipCoachingCollaborationCommunicationOrganizational Skills
Tools & Technologies
Microsoft Office Suite
Industry Keywords
Clinical ResearchPharmaceuticalBiotechnologyCROGlobal Clinical Trial RegulationsRare Disease TrialsService Provider OversightAudit PreparationOperational FeasibilityCross-Functional Team Leadership