Remote Early Clinical Scientist — Phase I Trials Lead

Parexel; Helena (MT); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking an Early Clinical Scientist to coordinate design, planning and execution of early phase trials with the Clinical Director and teams. You will oversee trials across programs, ensuring data validity and regulatory compliance while guiding internal and external collaborators.

This role requires strong experience in CRO management for Ph1 trials, CTMS/TMF proficiency, and capability to author protocol concepts and cross-functional documents.

Qualifications

• Experience in managing CROs from the Sponsor side for Ph1 clinical trials.
• Familiar with clinical trial management systems and TMF processes.
• Authoring Protocol Concepts and related study documents.
• Ability to lead cross-functional teams (regulatory, data, biomarker).
• Manage multiple projects concurrently.
• Review protocol, ICF, IB, CSR, biomarker processes, risk assessments.
• Proficient in GCP, ICH guidelines and regulatory requirements.

Responsibilities

• Coordinate design, planning and execution of early phase trials with Clinical Director and teams.
• Oversee trials across programs/therapeutic areas for data validity and safety.
• Co-author clinical sections of protocols, investigator brochures, and study reports.
• Develop operational documents: site monitoring plans, informed consent, operations manual.
• Manage trial projects, schedule meetings, and perform risk assessment.

Education

Bachelor's degree in Life Sciences

Master's degree in Life Sciences

PhD or doctorate in Life Sciences

Tools

CTMS

TMF systems

Job description

Parexel is seeking an Early Clinical Scientist to coordinate design, planning and execution of early phase trials with the Clinical Director and teams. You will oversee trials across programs, ensuring data validity and regulatory compliance while guiding internal and external collaborators.

This role requires strong experience in CRO management for Ph1 trials, CTMS/TMF proficiency, and capability to author protocol concepts and cross-functional documents.