Senior Clinical Project Coordinator

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

Location: Massachusetts (Remote - preference for EST hours)

A growing biotechnology company is seeking a Senior Clinical Project Coordinator to provide operational and administrative support for ongoing clinical studies. This individual will work closely with Clinical Study Leads and the Director of Clinical Operations to help keep study activities organized, documentation current, and key milestones on track.

The position will play an important role in maintaining the electronic Trial Master File (eTMF), reviewing clinical documentation for accuracy and completeness, and supporting the creation and upkeep of clinical operations procedures and templates in partnership with Quality Assurance (QA).

This role is well suited for someone with a background in clinical operations who is detail-oriented, comfortable managing multiple priorities, and able to adapt in a fast-paced biotech environment.

Key Responsibilities:

• Partner with Clinical Study Leads to gather, organize, distribute, maintain, and track essential clinical study documentation.
• Oversee the organization and ongoing maintenance of the electronic Trial Master File (eTMF), conducting completeness checks in accordance with established TMF plans.
• Review clinical study documents, including protocols and informed consent forms, for accuracy and quality before final approval, as needed.
• Distribute approved study materials, such as protocols and Investigator's Brochures, to internal stakeholders and external vendors.
• Support the administration and tracking of study-related contracts, budgets, purchase orders, invoices, and contract amendments in collaboration with Finance.
• Monitor screening and enrollment progress for assigned clinical studies and communicate updates during study meetings.
• Assist with user acceptance testing (UAT) for clinical databases and related study systems when required.
• Help investigate and reconcile discrepancies involving clinical trial supply shipments and biological sample shipments, as needed.
• Coordinate with cross-functional partners to support study deliverables, timelines, and overall execution.
• Organize clinical study team meetings, prepare and circulate agendas and materials, and follow up on outstanding action items.
• Maintain complete, accurate, and inspection-ready study records in accordance with applicable clinical documentation requirements.
• Contribute to the development and maintenance of clinical operations templates, work instructions, and standard operating procedures (SOPs), working alongside Clinical Operations leadership and QA.

Qualifications:

• Bachelor's Degree
• 2+ years of experience within the pharmaceutical or biotechnology industry.
• Familiarity with clinical operations activities, study documentation, and clinical trial processes.
• Basic understanding of Good Clinical Practice (GCP) and applicable ICH guidelines.
• Strong organizational skills, attention to detail, and the ability to maintain accurate documentation.
• Ability to manage multiple assignments, adjust to shifting priorities, and work effectively within a lean, collaborative organization.
• Strong written and verbal communication skills, with the ability to work effectively across internal teams and external partners.
• Practical problem-solving skills and a proactive approach to identifying and resolving issues.