Remote Early-Phase Clinical Scientist Lead

Parexel; Juneau (AK); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel FSP is seeking an experienced Clinical Scientist to lead or support early phase clinical studies, ensuring scientific integrity and protocol execution. The ECS collaborates with Clinical Directors and cross-functional teams to deliver data-ready trials on time.

Key responsibilities include oversight of study design, risk management, monitoring, protocol and ICF review, and authoring clinical sections of essential documents while maintaining compliance with ICH-GCP and Parexel standards.

Qualifications

• Experience managing CROs from the Sponsor side for Phase 1 trials.
• Use of Clinical Trial Management and Trial Master File systems.
• Authoring Protocol Concepts.
• Facilitating a Trial Team with cross functional partners (regulatory, data managers, statisticians, etc.).
• Knowledge of GCP, ICH guidelines and regulatory requirements.

Responsibilities

• Coordinate design, planning and execution of early phase trials with Clinical Director and team.
• Oversee trials to ensure excellence in execution and data validity.
• Lead or support study activities and manage project teams to meet objectives.
• Monitor safety assessment and risk management with accelerated timelines.
• Review and interpret trial data and co-author clinical sections of key documents.
• Develop study operational documents (site monitoring plan, ICF, etc.).

Education

Life Sciences degree

Bachelor's degree and ≥7 years related experience

Master's degree and ≥5 years related experience

PhD or doctorate degree and ≥1 year related experience

Job description

Parexel FSP is seeking an experienced Clinical Scientist to lead or support early phase clinical studies, ensuring scientific integrity and protocol execution. The ECS collaborates with Clinical Directors and cross-functional teams to deliver data-ready trials on time.

Key responsibilities include oversight of study design, risk management, monitoring, protocol and ICF review, and authoring clinical sections of essential documents while maintaining compliance with ICH-GCP and Parexel standards.