Remote: Early Clinical Scientist — Lead Phase I Trials

Parexel; Atlanta (GA); Remote; USD 110,000 - 160,000; Full time

Job summary

Parexel is seeking an Early Clinical Scientist (ECS) to lead or support early phase clinical studies. The ECS will be accountable for the clinical/scientific execution of the protocol, coordinating with the Clinical Director and cross-functional teams to ensure data integrity and regulatory compliance.

The role requires strong leadership, extensive knowledge of GCP/ICH guidelines, and proven ability to manage CROs and complex trial logistics in a fast-paced environment.

Qualifications

• Experience in managing CROs for Phase 1 trials.
• Authoring of protocol concepts and study documents.
• Familiarity with ICH-GCP and regulatory requirements.
• Experience with early drug development processes.
• Proven ability to collaborate with regulatory, data management and clinical teams.

Responsibilities

• Coordinate design, planning and execution of early phase clinical trials with multi-disciplinary teams.
• Provide oversight of trial execution to ensure data validity and protocol compliance.
• Monitor safety assessment and risk management under accelerated timelines.
• Co-author clinical sections of protocols, IBs and CSR documents.
• Mentor internal/external team members and manage budgets/vendors as needed.

Skills

MS Office

Team leadership

Communication

English proficiency

Multitasking

Project management

Cross-functional collaboration

Therapeutic area knowledge

Education

Bachelor's degree in Life Sciences

Master's degree

PhD or doctorate

Tools

CTMS

TMF systems

Job description

Parexel is seeking an Early Clinical Scientist (ECS) to lead or support early phase clinical studies. The ECS will be accountable for the clinical/scientific execution of the protocol, coordinating with the Clinical Director and cross-functional teams to ensure data integrity and regulatory compliance.

The role requires strong leadership, extensive knowledge of GCP/ICH guidelines, and proven ability to manage CROs and complex trial logistics in a fast-paced environment.