PTC Therapeutics, Inc. · 3 hours ago
Clinical Trial Associate I
New Jersey, United States
Full-time
Onsite
Entry Level
$82K/yr - $103K/yr
2+ years expPTC Therapeutics is a global commercial biopharmaceutical company committed to improving the lives of individuals with rare diseases. The Clinical Trial Associate I plays a vital role in supporting clinical trials by ensuring accurate documentation, coordinating activities, and maintaining compliance with regulatory standards.
BiotechnologyHealth CareTherapeutics
Responsibilities
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
Qualification
Required
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
Familiarity with clinical trial study documents
Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint)
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Preferred
Experience with TMFs. Performing periodic ad hoc, interim and end-of-study reviews/audits on paper and electronic TMFs for several trials to ensure TMF meets sponsor's expectations (includes TMF reconciliation at study close-out)
Benefits
Short- and long-term incentives
Medical, dental, vision, and retirement savings plans
Company
PTC Therapeutics, Inc.
PTC is a patient-centered biopharmaceutical company focused on discovering, developing & commercializing medicine for children and adults living with rare and serious disease.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.57BKey Investors
Brookside CapitalCredit Suisse First Boston
2022-10-27Post Ipo Equity· $1B
2020-05-14Post Ipo Equity· $140.95M
2015-08-14Post Ipo Debt· $150M
Leadership Team
Matthew B. Klein
Chief Executive Officer and President
Stuart Peltz
CEO
Recent News
2026-01-12
2026-01-09
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