Contractor, Clinical Trial Associate

PTC Therapeutics•Warren, MI

6d•Onsite

About The Position

The Clinical Trial Associate (CTA) supports the Clinical Operations Excellence (COE) function within the Clinical Operations department. This role provides day-to-day operational and administrative support to COE teams across Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance, helping ensure consistent processes, inspection-ready documentation practices, and effective use of clinical operations technologies. The Clinical Trial Associate (CTA) supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Bachelor’s degree in a relevant discipline and a minimum of 5+ years of clinical operations and/or clinical trial operations experience within the biotechnology or pharmaceutical industry.
Working knowledge of ICH-GCP, clinical trial documentation practices, and inspection readiness concepts.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
High attention to detail and comfort working with metrics, dashboards, and data quality checks.
Proficiency in Microsoft Office (Excel, PowerPoint, Word) and familiarity with clinical systems (e.g., CTMS, eTMF, eLearning/LMS).
Effective written and verbal communication; able to draft clear meeting minutes, status summaries, and user communications.
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.
Continuous improvement mindset; able to identify gaps, propose practical enhancements, and follow through.

Responsibilities

Coordinate and track general COE initiatives, deliverables, and timelines
Coordinate working group logistics (meeting scheduling, agendas, minutes, action item tracking) for COE activities.
Maintain COE-controlled repositories (e.g., COE mailbox, SharePoint/Teams sites) to ensure content is organized, searchable, and current
Support creation and upkeep of best practices, job aids, FAQs, and onboarding materials for Clinical Operations staff.
Assist with the development, formatting, publishing, and periodic review of Clinical Operations standards, templates, tools, and guidance documents.
Manage controlled documents and records relevant to COE (e.g., version control, distribution lists, archive/retention support).
Support IPR/TMF IPR activities with eTMF, such as periodic quality checks, completeness checks, and reconciliation support under direction of SMEs.
Support inspection-readiness activities, including tracking deliverables, maintaining readiness checklists, and monitoring action items.
Coordinate mock inspection or readiness meeting logistics and support follow-up documentation.
Help maintain centralized inspection-readiness resources and ensure consistent filing/naming conventions.
Support CAPA and issue tracking activities by maintaining logs, status updates, and meeting minutes, as directed.
Provide administrative support for clinical systems used by Clinical Operations (e.g., user access request coordination, training coordination, and basic user support triage).
Support system-related change management activities (e.g., communication drafts, training session logistics, and attendance tracking).
Ensure work is performed in compliance with applicable SOPs, GCP, internal standards, and data integrity expectations.
Interface effectively with department stakeholders to support COE initiatives.