Contractor, Clinical Trial Associate - Clinical Operations Excellence

PTC Therapeutics; New Jersey; On-site; USD 48,000 - 80,000; Full time

Job summary

PTC Therapeutics is seeking a Contractor, Clinical Trial Associate (CTA) to support the Clinical Operations Excellence (COE). You will help ensure SOP compliance, inspection readiness, and effective use of systems like CTMS and eTMF.

You will coordinate COE initiatives, manage documents, and support CAPA and issue tracking while operating within a fast-paced, matrixed team. Travel will be required 20–30%, with an hourly pay range disclosed by the company.

Qualifications

• Bachelor's degree in a relevant discipline and a minimum of 5+ years of clinical operations and/or clinical trial operations experience in biotech/pharma.
• 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 with metrics, dashboards, and data quality checks.
• Proficiency in Microsoft Office (Excel, PowerPoint, Word) and familiarity with clinical systems (CTMS, eTMF, eLearning/LMS).
• Ability to draft clear meeting minutes, status summaries, and user communications.
• Ability to work both independently and in a matrixed team environment.
• Analytical thinker with problem-solving skills and adaptability to changing priorities.

Responsibilities

• Coordinate and track COE initiatives, deliverables, and timelines.
• Coordinate working group logistics: scheduling, agendas, minutes, action item tracking.
• Maintain COE repositories (SharePoint/Teams) to keep content organized and current.
• Support development and upkeep of best practices, job aids, FAQs, and onboarding materials.
• Assist with production of standards, templates, tools, and guidance documents.
• Manage controlled documents and records (version control, distribution lists).
• Support IPR/TMF activities with eTMF, including quality checks and reconciliations.
• Support inspection-readiness activities and maintain readiness checklists.
• Coordinate mock inspections and readiness meetings, and document follow-ups.
• Maintain centralized inspection-readiness resources and filing naming conventions.
• Support CAPA and issue tracking with logs and meeting minutes.

Skills

Time management

Analytical thinking

Planning

Attention to detail

Education

Bachelor's degree in a relevant discipline

Tools

CTMS

eTMF

eLearning/LMS

Job description

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 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.

COE Systems Support

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.

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