Senior Clinical Operations Lead — Rare Disease Trials

PTC Therapeutics, Inc; Bridgeport (CT); Sur place; USD 137 000 - 172 000; Plein temps

Avantages offerts par ce poste

Incentives

Medical, dental, vision

Retirement savings plans

Résumé du poste

PTC Therapeutics, Inc is seeking a Senior Manager, Clinical Operations to oversee the planning, execution, and oversight of Phase I–IV clinical trials across development programs. You will collaborate with internal teams and external service providers to ensure quality, timelines, and budget adherence.

The role may include leadership of junior staff, ensuring SOPs and ICH-GCP compliance while driving operational strategy and study deliverables.

Qualifications

• 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 thinker with 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.

Responsabilités

• Lead or support the operational execution of Phase I-IV clinical trials, depending on study complexity and program needs.
• Serve as Lead Clinical Trial Manager for assigned studies, with responsibility for study timelines, operational strategy, and study deliverables.
• Contribute to the development planning and operational feasibility assessments.
• Develop and manage key study documents including: Clinical Trial Management Plans, Study timelines and 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 operational service providers to ensure delivery of services consistent with contracted agreements and study requirements.
• Participate in service provider selection, RFP development, and contract review.
• Monitor service provider performance, study metrics, and key performance indicators to ensure study quality, and timelines are maintained.
• Partners with internal functions including Clinical Development, Data Management, Biostatistics, Regulatory Affairs, Medical Writing, Project Management, Clinical Supply, and Quality Assurance.
• Ensure alignment of operational study and overall program strategy and development timelines.
• Ensure clinical trials are conducted in accordance with ICH-GCP guidelines, applicable global regulatory requirements, company policies and SOPs.
• Support inspection readiness and contribute to audit preparations and follow-up activities.
• Identify operational risks and develop mitigation and contingency strategies.
• Provide oversight of site identification, feasibility, selection, and activation activities.
• Review monitoring reports and key study metrics to ensure appropriate study oversight.
• Support resolution of site issues, enrollment challenges, and protocol implementation questions.
• Contribute to study budget development and ongoing financial oversight.
• Monitor study progress against timelines, milestones, and performance metrics.
• Identify potential risks to study execution and implement corrective actions as needed.
• May manage and develop direct reports; provide mentorship and oversight of junior Clinical Operations staff.
• Support performance management, professional development, and training of team members.
• Foster a collaborative and high-performing clinical operations team environment.
• Contributes to preparation of study management plans, service provider oversight documentation, and operational reports.
• Provides regular updates on study status, risks, and mitigation strategies to Clinical Operations Leadership.
• Ensure study documentation is maintained in accordance with company requirements and is inspection ready.

Connaissances

ICH-GCP knowledge

Leadership

Cross-functional collaboration

Project management

Risk management

Analytical thinking

Communication

Strategic oversight

Formation

Bachelor's degree in a scientific discipline

Outils

Microsoft Office Suite

Description du poste

PTC Therapeutics, Inc is seeking a Senior Manager, Clinical Operations to oversee the planning, execution, and oversight of Phase I–IV clinical trials across development programs. You will collaborate with internal teams and external service providers to ensure quality, timelines, and budget adherence.

The role may include leadership of junior staff, ensuring SOPs and ICH-GCP compliance while driving operational strategy and study deliverables.