Senior Clinical Operations Coordinator (Remote EST)

Syntagma Group; United States; Remote; USD 80,000 - 110,000; Full time

Job summary

Syntagma Group is seeking a Senior Clinical Project Coordinator in Massachusetts, with a remote work option and preference for EST hours. You will support clinical studies by organizing essential documentation, maintaining the eTMF, and helping prepare SOPs with QA.

This role requires attention to detail, process discipline, and effective cross-functional collaboration. Responsibilities include dataset and TMF management, document reviews, material distribution, and coordination with Finance on

Qualifications

• 2+ years of experience in the pharmaceutical or biotechnology industry.
• Familiarity with clinical study documentation and TMF.
• Knowledge of GCP and ICH guidelines.
• Strong organizational and communication skills.

Responsibilities

• Partner with Clinical Study Leads to organize and track essential clinical study documentation.
• Oversee eTMF maintenance and completeness checks per TMF plans.
• Review study documents for accuracy before final approval.
• Distribute approved materials to internal stakeholders and external vendors.
• Assist with contracts, budgets, POs, invoices, and amendments with Finance.
• Monitor screening/enrollment progress and share updates in study meetings.
• Support user acceptance testing for clinical databases and study systems.
• Investigate discrepancies in trial supply and biological sample shipments.
• Coordinate with cross-functional partners to support study deliverables and timelines.
• Organize study team meetings, circulate agendas, and track action items.
• Maintain inspection-ready study records per regulatory requirements.
• Contribute to SOPs, templates, and work instructions with Clinical Ops and QA.

Skills

Organization

Communication

Problem solving

Documentation

Clinical operations knowledge

GCP knowledge

Education

Bachelor's Degree

Job description

Syntagma Group is seeking a Senior Clinical Project Coordinator in Massachusetts, with a remote work option and preference for EST hours. You will support clinical studies by organizing essential documentation, maintaining the eTMF, and helping prepare SOPs with QA.

This role requires attention to detail, process discipline, and effective cross-functional collaboration. Responsibilities include dataset and TMF management, document reviews, material distribution, and coordination with Finance on