Clinical Trial Operations Lead

PTC Therapeutics, Inc; Connecticut; Sur place; USD 48 000 - 80 000; Plein temps

Résumé du poste

PTC Therapeutics, Inc is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. The role provides day-to-day operational support across COE standards, IPR, systems, and Vendor Alliance, ensuring inspection-ready documentation and effective use of clinical operations technologies.

Responsibilities include coordinating COE initiatives, maintaining controlled documents, and assisting with SOPs, tools, and onboarding materials, under SME

Qualifications

• Bachelor's degree in a relevant discipline and 5+ years in clinical operations or trial ops.
• Knowledge of ICH-GCP, clinical trial documentation, and inspection readiness.
• Strong planning, organization, and time management skills.

Responsabilités

• Coordinate COE initiatives, deliverables and timelines.
• Maintain COE repositories and prepare onboarding materials.
• Support development and review of SOPs, templates, and guidance documents.
• Assist with CAPA and issue tracking; track action items and minutes.

Connaissances

ICH-GCP familiarity

Meeting minutes

MS Office

CTMS/eTMF knowledge

Analytical thinking

Formation

Bachelor's degree

Outils

CTMS

eTMF

LMS

Description du poste

PTC Therapeutics, Inc is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence function. The role provides day-to-day operational support across COE standards, IPR, systems, and Vendor Alliance, ensuring inspection-ready documentation and effective use of clinical operations technologies.

Responsibilities include coordinating COE initiatives, maintaining controlled documents, and assisting with SOPs, tools, and onboarding materials, under SME