Remote Early Clinical Scientist: Lead Early-Phase Trials

Parexel; Dover (DE); À distance; USD 90 000 - 130 000; Plein temps

Résumé du poste

Parexel is seeking an Early Clinical Scientist to lead or support early phase clinical studies, accountable for the clinical/scientific execution of protocols. The ECS will coordinate design, planning and real-time oversight in collaboration with the Clinical Director and cross-functional teams.

The role requires managing CROs, TMF systems, and protocol documentation under stringent timelines, with strong written/spoken English and ability to work with diverse partners.

Qualifications

• Experience in managing CROs from the Sponsor side for Phase 1 clinical trials
• Use of Clinical Trial Management and Trial Master File systems
• Authoring Protocol Concepts
• Facilitating a Trial Team with cross functional partners such as regulatory, clinical supplies managers, data managers, statisticians, programmers, procurement, etc.
• Reviewing protocol, ICF, IB, CSR, biomarker process, site and medical monitoring plans, risk assessment, protocol deviations

Responsabilités

• Coordinate the design, planning and execution of early phase clinical trials in collaboration with the Clinical Director and team
• Oversee trials across programs to ensure excellence in execution and data validity
• Manage trial and program projects including team activities and performance of internal/external teams
• Provide risk assessment and contingency planning under accelerated timelines
• Co-author clinical sections of protocols, investigator brochures, study reports and ensure compliance with standards
• Develop study operational documents with input from team (site monitoring plan, ICF, etc.)
• Review budgets and approve vendor invoices when required

Connaissances

MS Office Suite

Team collaboration

English proficiency

Multitasking

Complex operations

Cross-functional partnership

Scientific knowledge

GCP knowledge

Formation

Bachelor's degree + 7+ years

Master's degree + 5+ years

PhD/doctorate + 1+ year

Description du poste

Parexel is seeking an Early Clinical Scientist to lead or support early phase clinical studies, accountable for the clinical/scientific execution of protocols. The ECS will coordinate design, planning and real-time oversight in collaboration with the Clinical Director and cross-functional teams.

The role requires managing CROs, TMF systems, and protocol documentation under stringent timelines, with strong written/spoken English and ability to work with diverse partners.