United States onlyJob Description Summary:
The Director, Clinical Central & Oversight Monitoring Lead is responsible for the strategic leadership, implementation, and execution of centralized and oversight monitoring across clinical programs and within the clinical trials. This role ensures robust risk-based monitoring (RBM) strategies, data-driven decision-making, and proactive risk identification to enhance subject safety, data integrity, and trial efficiency.The Director, Clinical Central & Oversight Monitoring Lead will oversee both central monitoring activities and oversight monitoring responsibilities, ensuring compliance with regulatory standards while driving continuous improvement in clinical trial execution. This position will influence senior leadership and key stakeholders by providing insights and recommendations on optimizing clinical trial monitoring strategies.
The Director, Clinical Central & Oversight Monitoring Lead requires close collaboration with cross-functional teams, including Clinical Operations, Data Management, Biostatistics, and Quality Assurance, and Clinical Research Organizations to optimize clinical monitoring processes and ensure compliance with regulatory requirements and Standard Operating Procedures as appropriate.
The Director, Clinical Central & Oversight Monitoring Lead manages direct report(s).
Job Description:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- Develop and implement a comprehensive central and oversight monitoring strategy aligned with risk-based monitoring principles.
- Provide leadership to establishing key risk indicators (KRIs) and performance metrics for site and trial-level monitoring.
- Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory requirements for central monitoring and oversight.
- Drive innovation by integrating emerging technologies, data analytics, and other tools into central and oversight monitoring processes.
- Lead the design, execution, and continuous refinement of central monitoring processes to proactively identify trends, anomalies, and site and/or CRA performance risks.
- Oversee the development and application of data analytics models to detect protocol deviations, missing data, safety signals, and site quality concerns.
- Ensure timely escalation and resolution of site and trial risks by working closely with members from Clinical Operations, Data Management, and Biostatistics.
- Implement quality oversight measures to monitor the performance of both sponsor and CRO-led clinical monitoring activities.
- Provide, establish, and implement oversight of site monitoring strategies:
ESSENTIAL FUNCTIONS
Primary duties/responsibilities:
- Develop and implement a comprehensive central and oversight monitoring strategy aligned with risk-based monitoring principles.
- Provide leadership to establishing key risk indicators (KRIs) and performance metrics for site and trial-level monitoring.
- Ensure compliance with ICH-GCP, FDA, EMA, and other regulatory requirements for central monitoring and oversight.
- Drive innovation by integrating emerging technologies, data analytics, and other tools into central and oversight monitoring processes.
- Lead the design, execution, and continuous refinement of central monitoring processes to proactively identify trends, anomalies, and site and/or CRA performance risks.
- Oversee the development and application of data analytics models to detect protocol deviations, missing data, safety signals, and site quality concerns.
- Ensure timely escalation and resolution of site and trial risks by working closely with members from Clinical Operations, Data Management, and Biostatistics.
- Implement quality oversight measures to monitor the performance of both sponsor and CRO-led clinical monitoring activities.
- Provide, establish, and implement oversight of site monitoring strategies:
- To ensure adherence to study protocols, GCP guidelines, and industry best practices.
- To assess the quality and effectiveness of site and CRO monitoring activities.
- Review site monitoring reports, visit trends, and compliance data to ensure timely and effective monitoring interventions.
- Evaluate site performance metrics, including enrollment, protocol compliance, and data quality, and implement corrective action as needed.
- Conduct monitoring oversight visits and co-monitoring activities as necessary to ensure sites and CROs meet expectations for monitoring and trial execution.
- Ensure that monitoring findings are appropriately documented, addressed, and resolved in collaboration with key stakeholders.
- Develop training programs for clinical monitoring teams, site staff, and CROs on central and oversight monitoring methodologies at PTC.
- Act as a subject matter expert (SME) in audits and regulatory inspections, ensuring readiness and adherence to monitoring compliance standards.
- Build and mentor a high-performing team of central monitors, ensuring ongoing professional development and expertise in risk-based monitoring and monitoring oversight.
- Manage, coach, and mentor direct reports.
- Perform other tasks and assignments as needed and specified by management.
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
- Bachelor’s degree in Life Sciences, Nursing, Public Health, or a relevant field with a minimum of 10 years of experience in clinical research, and a strong focus on clinical monitoring, central monitoring, and oversight monitoring strategies: equivalent education and experience may be considered.
* Special knowledge or skills needed and/or licenses or certificates required.
- Proven leadership experience in directing risk-based monitoring, central monitoring, and oversight monitoring strategies.
- Strong understanding of ICH-GCP, FDA, EMA, and other global regulatory requirements for central monitoring and oversight.
- Previous clinical monitoring experience and experience in oversight of CROs and vendor monitoring activities.
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC), and central monitoring platforms.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- An analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills include the ability to support and prioritize multiple projects.
- Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
- Ability to influence without direct authority.
- Excellent verbal and written communication skills.
- Proficiency with Microsoft Office Suite
*Special knowledge or skills and/or licenses or certificates preferred.
- Prior involvement in Investigational New Drug applications (INDs) and New Drug Applications (NDAs) submissions.
- People and project management experience.
* Travel requirements
Travel up to 25% for site visits, co-monitoring activities, meetings and conferences.
Office based position
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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