Lead Early-Phase Clinical Scientist (Remote)

Parexel; Lansing (MI); Teletrabalho; USD 120 000 - 190 000; Tempo integral

Resumo da oferta

Parexel is seeking an Early Clinical Scientist to lead or support early phase studies, ensuring clinical/scientific execution of the protocol. The ECS will coordinate with the Clinical Director and cross-functional teams to deliver high-quality data and compliant trial conduct.

Key responsibilities include oversight of trial execution, risk management, protocol writing, and collaboration with regulators, data managers, and statisticians.

Qualificações

• Experience in managing CROs from Sponsor side for Phase 1 trials.
• Familiarity with Clinical Trial Management and Trial Master File systems.
• Ability to author Protocol Concepts and related clinical documents.
• Experience coordinating with regulatory, data managers, statisticians, and other cross-functional partners.

Responsabilidades

• Coordinate design, planning and execution of early phase clinical trials
• Oversee trials within programs and ensure data validity and trial objectives
• Manage internal/external team performance and resolve issues
• Provide risk assessment and contingency planning under accelerated timelines
• Co-author clinical sections of protocols, ICFs, IBs and CSR
• Develop study operational documents and ensure compliance with standards
• Review budgets and invoices for payments to vendors

Conhecimentos

MS Office

Team collaboration

English proficiency

Multitask / prioritization

Scientific writing

Therapeutic area knowledge

Regulatory awareness

Problem solving

Communication (verbal)

Formação académica

Bachelor's degree + 7+ years experience

Master's degree + 5+ years experience

PhD or doctorate + 1+ year experience

Life Sciences degree

Descrição da oferta de emprego

Parexel is seeking an Early Clinical Scientist to lead or support early phase studies, ensuring clinical/scientific execution of the protocol. The ECS will coordinate with the Clinical Director and cross-functional teams to deliver high-quality data and compliant trial conduct.

Key responsibilities include oversight of trial execution, risk management, protocol writing, and collaboration with regulators, data managers, and statisticians.