Director, Clinical Monitoring Oversight Lead

Employment Type: Full time

Company Information

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years, our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture! Site: www.ptcbio.com

Position Overview

PTC is committed to providing access to best-in-class treatments for patients with little to no treatment options. This mission underpins our focus on the discovery, development, and global commercialization of clinically differentiated medicines for those with rare diseases. As a patient-centric, global pharmaceutical company, we combine clinical and scientific expertise with groundbreaking science and technology, always with the patient in mind. We work hard to provide broad access to our life-changing treatments. What drives us is our passion to provide patients with more moments with their families.

The Director, Clinical Monitoring Oversight Lead is tasked with providing strategic leadership and overseeing clinical trial monitoring activities, ensuring adherence to regulatory standards and data integrity. This position involves crafting and executing comprehensive monitoring oversight strategies and plans and leveraging risk-based monitoring approaches. The Director, Clinical Monitoring Oversight Lead manages direct report(s). The incumbent works cross-functionally with internal and external partners to guarantee the successful monitoring of clinical trials. The Director, Clinical Monitoring Oversight Lead ensures compliance with regulatory requirements, ICH-GCP guidelines, and the company's Standard Operating Procedures (SOPs).

Responsibilities

• Develop and implement a comprehensive oversight monitoring strategy and plans to ensure integrity and safety of clinical trials.
• Provide leadership to establishing key risk indicators (KRIs) and performance metrics for site and trial-level monitoring.
• Drive innovation by integrating emerging technologies, data analytics, and other tools into oversight monitoring processes.
• Lead the design, execution, and continuous refinement of 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, Clinical Development, Data Management, Biostatistics, and Quality.
• 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 relevant guidelines.

Requirements

(No specific requirements were provided in the original text.)

Application Instructions

(No specific application instructions were provided in the original text.)