Contractor, Clinical Trial Associate - Clinical Operations Excellence

PTC Therapeutics, Inc; Bridgeport (CT); Vor Ort; USD 48.000 - 80.000; Vollzeit

Zusammenfassung

PTC Therapeutics, Inc. is seeking a Contractor, Clinical Trial Associate to support the COE within Clinical Operations. You will coordinate initiatives, maintain documents, and assist with ICH-GCP compliance and SOP adherence across systems.

Responsibilities include coordinating meetings, updating repositories, supporting TMF/IPR activities, and ensuring inspection readiness while communicating clearly with internal and external stakeholders in a fast-paced biotech environment.

Qualifikationen

• Bachelor's degree in a relevant discipline; 5+ years of clinical operations experience.
• Working knowledge of ICH-GCP, clinical trial documentation practices, and inspection readiness.
• Excellent planning, organization and time management skills.
• Proficiency in Microsoft Office and familiarity with clinical systems (CTMS, eTMF, eLearning/LMS).
• Effective written and verbal communication; able to draft clear meeting minutes, status summaries, and user communications.

Aufgaben

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate working group logistics (meetings, agendas, minutes, action items).
• Maintain COE-controlled repositories (SharePoint/Teams) to ensure content is organized, searchable, and current.
• Assist with development, formatting, publishing, and periodic review of COE standards, templates, tools, and guidance documents.
• Support IP/TMF IPR activities with eTMF and reconcile under direction of SMEs.
• Support inspection-readiness activities, including tracking deliverables and readiness checklists.

Kenntnisse

ICH-GCP knowledge

Planning & organization

Attention to detail

MS Office proficiency

Communication skills

Independent & collaborative work

Analytical thinking

Ausbildung

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

eLearning/LMS

Microsoft Office

Jobbeschreibung

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.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary: Job Description

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

ESSENTIAL FUNCTIONS

• 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 materialsfor 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).
• SupportIPR/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.

COE Systems Support

• Provide administrative support forclinical systemsused 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.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• 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.

* Special knowledge or skills needed and/or licenses or certificates required.

• 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.

* Travel requirements

• 20-30%

Expected Hourly Range:

$35 - $58/hour. The hourly salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.