Remote Early Clinical Scientist - Phase I Trials Lead

Parexel; Montpelier (VT); Remote; USD 110,000 - 160,000; Full time

Job summary

Parexel FSP has an exciting opportunity for a Clinical Scientist. The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members.

Oversees trials within and across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity. Manages internal/external team performance to achieve project objectives and resolves project

Qualifications

• Degree in Life Sciences as a base requirement.
• Experience with CROs for Ph1 trials and TMF systems.
• Proficient in protocol concepts and regulatory writing.
• Ability to lead cross-functional trial teams and manage multiple projects.
• Experience reviewing protocols, ICF, IB and CSR.

Responsibilities

• Coordinate design, planning and execution of early phase trials.
• Oversee trials across programs to ensure data validity.
• Provide real-time safety and risk management oversight.
• Review and interpret clinical trial data for decisions.
• Conduct on-site monitoring and site training supervision.
• Apply GCP, ICH guidelines and regulatory requirements.
• Lead trial teams and manage timelines and risks.

Skills

CRO management

TMF systems

Protocol concepts

Cross-functional leadership

Multi-project management

GCP/ICH knowledge

Scientific writing

Team communication

Regulatory collaboration

Trial data review

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

PhD or Doctorate

Tools

Microsoft Teams

Job description

Parexel FSP has an exciting opportunity for a Clinical Scientist. The Early Clinical Scientist/ECS coordinates the design, planning and execution of early phase clinical trials with the Clinical Director, and internal/external team members.

Oversees trials within and across program(s)/therapeutic areas and ensures excellence in execution/compliance to support study objectives and data validity. Manages internal/external team performance to achieve project objectives and resolves project