Remote Early Clinical Scientist – Phase I Trials

Parexel; Augusta (ME); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking an Early Clinical Scientist (ECS) to coordinate design, planning, and execution of early phase trials in collaboration with the Clinical Director and diverse teams. You will oversee trials to ensure alignment with objectives, data integrity, and regulatory compliance.

Responsibilities include authoring protocol concepts, managing trial documents, and leading cross-functional teams across regulatory, data, and clinical operations, with an emphasis on safety and risk management.

Qualifications

• Experience managing CROs from Sponsor side for Ph1 trials.
• Experience with CTMS and Trial Master File systems.
• Authoring Protocol Concepts.
• Ability to lead and coordinate cross-functional teams.

Responsibilities

• Coordinate design, planning and execution of Early Phase trials with clinical director.
• Oversee trials across programs and ensure compliance and data validity.
• Co-author protocols, investigator brochures, and study reports.
• Manage study documents and risk management processes.

Skills

Clinical trial management

Cross-functional leadership

Regulatory knowledge

GCP/ICH familiarity

Scientific writing

Project coordination

Team collaboration

Education

Life Sciences degree

7+ years CRO/ph1 experience

Master's degree or PhD beneficial

Tools

CTMS

Trial Master File systems

Microsoft Teams

Job description

Parexel is seeking an Early Clinical Scientist (ECS) to coordinate design, planning, and execution of early phase trials in collaboration with the Clinical Director and diverse teams. You will oversee trials to ensure alignment with objectives, data integrity, and regulatory compliance.

Responsibilities include authoring protocol concepts, managing trial documents, and leading cross-functional teams across regulatory, data, and clinical operations, with an emphasis on safety and risk management.