Remote Early Clinical Scientist - Phase I Trials Lead

Parexel; Boise (ID); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel FSP is seeking a Clinical Scientist to lead or support early phase studies, accountable for the clinical and scientific execution of the protocol. The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity.

The ECS is responsible for coordinating design, planning and execution in collaboration with the Clinical Director and internal/external team members, ensuring data validity and protocol integrity across programs and

Qualifications

• Experience in 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 regulatory, clinical supplies, data, stats, programmers, procurement, etc.
• Knowledge of GCP and ICH guidelines and regulatory requirements.

Responsibilities

• Coordinate design, planning and execution of early phase clinical trials in collaboration with the Clinical Director and team.
• Oversee trials across programs/therapeutic areas and ensure excellence in execution and data validity.
• Manage trial and program projects including team activities and documentation.
• Monitor and mitigate patient, study design, data or conduct issues in real time.
• Co-author clinical sections of protocols and related documents in compliance with standards.
• Develop study operational documents (site monitoring plan, study ops manual, informed consent).
• Review budgets and approve vendor invoices when needed.

Skills

MS Office

Cross-functional collaboration

English proficiency

Project management

Team leadership

Attention to detail

Internal/external collaboration

Education

Bachelor's in Life Sciences with 7+ years experience

Master's degree with 5+ years experience

PhD with 1+ year experience

Tools

CTMS

Trial Master File (TMF) systems

Job description

Parexel FSP is seeking a Clinical Scientist to lead or support early phase studies, accountable for the clinical and scientific execution of the protocol. The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity.

The ECS is responsible for coordinating design, planning and execution in collaboration with the Clinical Director and internal/external team members, ensuring data validity and protocol integrity across programs and