Contractor, Clinical Trial Associate – Clinical Operations Excellence

PTC Therapeutics, Inc.

. Coordinate and track general Clinical Operations Excellence initiatives, deliverables, and timelines .

Posted 10/30/2026full-timeUnited StatesMid-Level💰 $35 - $58 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Operations Excellence, including coordination of initiatives, compliance with SOPs and GCP, and management of clinical trial documentation. Proficient in Microsoft Office and clinical systems, with strong organizational, analytical, and communication skills.

Highest-signal resume keywords

Clinical Operations ExperienceICH-GCP KnowledgeMicrosoft Office ProficiencyInspection Readiness SupportAnalytical Thinking

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial DocumentationControlled Document ManagementQuality ChecksMetrics AnalysisProject Coordination

Soft Skills

Planning SkillsAttention to DetailEffective CommunicationProblem-Solving SkillsCollaboration Skills

Tools & Technologies

CTMSETMFSharePointTeamsELearning/LMS

Industry Keywords

BiotechnologyPharmaceutical IndustrySOP ComplianceCAPA TrackingContinuous Improvement

About the role

Key responsibilities & impact

Coordinate and track general Clinical Operations Excellence initiatives, deliverables, and timelines
Coordinate working group logistics, including meeting scheduling, agendas, minutes, and action-item tracking
Maintain COE-controlled repositories, including COE mailbox and SharePoint/Teams sites
Support creation and maintenance of best practices, job aids, FAQs, and onboarding materials
Assist with development, formatting, publishing, and review of Clinical Operations standards, templates, tools, and guidance documents
Manage controlled documents and records, including version control, distribution lists, and archive/retention support
Support eTMF IPR activities through periodic quality checks, completeness checks, and reconciliation
Support inspection-readiness activities, checklists, deliverable tracking, and action-item monitoring
Coordinate mock inspection or readiness meeting logistics and follow-up documentation
Maintain centralized inspection-readiness resources and consistent filing/naming conventions
Support CAPA and issue tracking through logs, status updates, and meeting minutes
Provide administrative support for clinical systems, including user-access requests, training coordination, and basic user-support triage
Support system change-management activities, communications, training logistics, and attendance tracking
Ensure compliance with SOPs, GCP, internal standards, and data-integrity expectations
Interface with department stakeholders to support COE initiatives

Requirements

What you’ll need

Bachelor’s degree in a relevant discipline
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 in a fast-paced, matrixed team environment with internal and external team members
Analytical thinking and problem-solving skills; ability to adapt to changing priorities and deadlines
Continuous improvement mindset; ability to identify gaps, propose practical enhancements, and follow through
Willingness to travel 20–30%