Clinical Trial Associate I

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.

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The Clinical Trial Associate I (CTA) is a key support role within the Clinical Operations department, contributing to the execution of clinical trials that advance innovative therapies for patients with rare and serious diseases. The CTA provides essential administrative, documentation, and coordination support across all phases of clinical trial management. Working under Clinical Trial Managers (Lead CTMs and/or CTMs), the CTA ensures that trial documentation is accurate, complete, and compliance, and that study activities are well-organized and efficiently executed in alignment with regulatory guidelines and PTC’s quality standards.

with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment. This position may also provide support in project team meetings by capturing meeting minutes/action items and following up with action item owners to ensure tasks are completed.

The incumbent works cross-functionally with internal departments and external resources on clinical study related issues.

The Clinical Trial Associate I supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Assists in the collection, review, and tracking of essential regulatory and clinical trial documents throughout the lifecycle of the study.
• Supports the set-up, organization, and maintenance of the Trial Master File (TMF), ensuring ongoing inspection readiness and compliance with ICH-GCP and internal SOPs.
• Helps coordinate clinical trial start-up, maintenance and close out activities, including the preparation of study materials, meeting logistics, and distribution of study communication.
• Assists in the development and management of study trackers, tools, and logs (e.g., site contact lists, enrollment logs, action items trackers).
• Schedules and supports internal and external study meetings, including investigator meetings, vendor calls, and cross-functional team discussions; prepares agendas and meeting minutes as needed.
• Interfaces with Clinical Research Organizations, vendors, and clinical sites to support study related tasks and documentation collection.
• Participants in review of monitoring reports and site-level documents such as informed consent forms and training logs.
• Supports TMF quality control and audit preparation activities.
• Assists in maintaining clinical trial management systems (e.g., CTMS), ensuring timely updates and accuracy of study status and documentation.
• Facilitates and supports study-level contracting and procurement workflows in partnership with Legal and Finance, leveraging enterprise systems.
• Collaborates with cross-functional teams (e.g., Regulatory, Data Management5, Clinical Supplies) to support ongoing study operations.
• Participates in onsite co-monitoring and monitoring oversight visits with CTM.
• Performs other tasks and assignments as needed and specified by management.

• Minimum level of education and years of relevant work experience.
• Bachelor’s degree in a relevant life science or healthcare-related discipline and minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment or a recognized equivalent of education and experience.
• Special knowledge or skills needed and/or licenses or certificates required.
• Familiarity with clinical trial study documents.
• Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Pro…