Sr Clinical Trial Associate COE Consultant

Title: Sr Clinical Trial Associate COE Consultant

Job Location: Berkeley Heights, NJ

Job Type: Contract to hire

Work arrangement: 1 day/week or 1 day/month

Category: Clinical Operations / Clinical Development

Industry: Biotechnology / Pharmaceuticals

The Challenge

Our client, a global biopharmaceutical organization dedicated to developing innovative therapies for patients living with rare diseases, is seeking an experienced Clinical Trial Associate COE Consultant to support its Clinical Operations Excellence (COE) function.

This role provides essential operational and administrative support across Clinical Operations Standards, Inspection Preparedness and Readiness (IPR), Systems, and Vendor Alliance initiatives. The ideal candidate brings strong clinical trial operations experience, exceptional organizational skills, and a thorough understanding of clinical documentation, eTMF, regulatory compliance, and inspection-readiness processes.

Key Responsibilities

• Clinical Operations Excellence & Project Coordination
• Coordinate COE initiatives, deliverables, project timelines, and cross-functional activities.
• Organize working group meetings, including scheduling, agendas, meeting minutes, and action-item tracking.
• Maintain departmental repositories, including SharePoint, Microsoft Teams, and centralized COE resources.
• Support the development and maintenance of best practices, job aids, FAQs, onboarding materials, and operational guidance.
• Assist with creating, formatting, publishing, and periodically reviewing Clinical Operations standards, templates, and procedures.
• Inspection Readiness & Clinical Documentation
• Support eTMF inspection-readiness activities, including document quality checks, completeness reviews, and reconciliation.
• Maintain inspection-readiness checklists, deliverable trackers, and action-item logs.
• Coordinate mock inspection meetings and document follow-up activities.
• Maintain centralized inspection-readiness resources and consistent document filing practices.
• Support controlled document management, including version control, distribution, archiving, and retention.
• Assist with CAPA tracking, issue logs, and status reporting.

Clinical Systems & Operational Support

• Provide administrative support for clinical systems, including CTMS, eTMF, and learning management platforms.
• Coordinate system access requests, training activities, and basic user support.
• Assist with system change management initiatives, communications, and training logistics.
• Support clinical systems adoption and consistent use of operational tools.
• Ensure activities comply with company SOPs, ICH-GCP, internal standards, and data integrity requirements.
• Identify opportunities to improve operational processes, documentation practices, and team efficiency.

Required Qualifications

• Bachelor's degree in a relevant discipline.
• Minimum 5+ years of clinical operations or clinical trial operations experience within the pharmaceutical or biotechnology industry.
• Working knowledge of ICH-GCP, clinical trial documentation, and regulatory inspection-readiness requirements.
• Experience supporting clinical documentation, controlled records, SOPs, and operational processes.
• Familiarity with clinical systems, including CTMS, eTMF, and eLearning/LMS platforms.
• Proficiency in Microsoft Office, including Excel, PowerPoint, and Word.
• Experience using SharePoint, Microsoft Teams, or similar document management and collaboration platforms.
• Excellent organizational, planning, time management, and multitasking skills.
• Strong attention to detail and ability to support metrics, dashboards, and data quality checks.
• Effective written and verbal communication skills, including preparing meeting minutes, status updates, and stakeholder communications.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
• Strong analytical, problem-solving, and continuous improvement skills.