Early-Phase Clinical Scientist — Remote Lead

Parexel; Olympia (WA); Remote; USD 120,000 - 160,000; Full time

Job summary

Parexel FSP has an exciting opportunity for a Clinical Scientist. The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity.

The ECS is accountable for the clinical/scientific execution of the protocol. Parexel FSP expects you to coordinate design, planning and execution of early phase trials with the Clinical Director and team, oversee such trials to ensure data validity, and develop study documents.

Qualifications

• Experience managing CROs from 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, etc).
• Understanding clinical research development from planning to regulatory submission.
• Scientific, medical and/or safety writing and reporting.
• Knowledge of GCP, ICH guidelines and regulatory requirements.
• Familiarity with early drug development processes.

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.
• Manage trial and program projects and team activities.
• Monitor ongoing trials to identify and mitigate issues.
• Co-author clinical sections of protocols and study documents.
• Develop study operational documents (site monitoring plan, consent, etc.).
• Review budgets and approve vendor invoices when needed.

Skills

MS Office

Leadership

Communication

English proficiency

Project management

Cross-functional collaboration

Problem solving

Education

Life Sciences degree

Bachelors + 7 years experience

Masters + 5 years experience

PhD or doctorate + 1 year

Tools

CTMS

TMF systems

Job description

Parexel FSP has an exciting opportunity for a Clinical Scientist. The Early Clinical Scientist (ECS) may lead or support an early phase clinical study or studies, depending on size/complexity.

The ECS is accountable for the clinical/scientific execution of the protocol. Parexel FSP expects you to coordinate design, planning and execution of early phase trials with the Clinical Director and team, oversee such trials to ensure data validity, and develop study documents.