Remote Early-Phase Clinical Scientist: Study Leadership

Parexel; Honolulu (HI); Remoto; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Parexel is seeking an Early Clinical Scientist to lead or support early phase studies, ensuring clinical/scientific execution of the protocol. The ECS collaborates with internal and external teams, monitors trial safety and data, and authors critical protocol documents and reports.

The role requires experience with CRO management, strong writing skills, and the ability to handle multiple projects under tight timelines while adhering to GCP/ICH standards.

Competenze

• Experience coordinating early phase clinical trials, with responsibility for clinical/scientific execution of protocols.
• Experience managing CROs from Sponsor side for Phase 1 trials is preferred.
• Knowledge of GCP, ICH guidelines and regulatory requirements.
• Ability to manage multiple projects and teams under accelerated timelines.

Mansioni

• Coordinate design, planning and execution of early phase clinical trials with Clinical Director and team.
• Provide oversight of trials across programs to ensure data validity and protocol compliance.
• Co-author protocol concepts, Investigator's Brochures, and study reports as needed.
• Develop study operational documents (sOPs, ICFs, monitoring plans).
• Review budgets and vendor invoices when required.

Conoscenze

MS Office

Team leadership

Communication skills

English proficiency

Multi-project management

Cross-functional collaboration

Scientific writing

GCP/ICH knowledge

Pharmacology knowledge

Strategic planning

Formazione

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

PhD or doctorate in Life Sciences

Strumenti

CTMS

eTMF systems

Descrizione del lavoro

Parexel is seeking an Early Clinical Scientist to lead or support early phase studies, ensuring clinical/scientific execution of the protocol. The ECS collaborates with internal and external teams, monitors trial safety and data, and authors critical protocol documents and reports.

The role requires experience with CRO management, strong writing skills, and the ability to handle multiple projects under tight timelines while adhering to GCP/ICH standards.