Remote Local Study Director, Oncology Trials

Parexel; Helena (MT); Remote; USD 150,000 - 210,000; Full time

Job summary

Parexel is seeking a Local Study Associate Director (LSAD) for a remote role in the US. Oncology experience required; cell therapy preferred. Leads Local Study Team to deliver study components within budget and timelines, ensuring compliance with ICH-GCP and local regulations.

The LSAD may perform site monitoring, coordinate site selection, and oversee CTMS and eTMF activities, while managing risks and patient recruitment strategies across country sites.

Qualifications

• Minimum 3 years of experience in Development Operations (CRA/SrCRA) or related field.
• Good knowledge of ICH-GCP and local regulations.
• Fluent in written and spoken English; local language skills a plus.
• Willingness to travel nationally and internationally as required.
• Bachelor’s degree in life science or related discipline.

Responsibilities

• Lead Local Study Team and ensure on-time data delivery with quality.
• Coordinate site selection, feasibility, and Site Qualification Visits.
• Oversee monitoring activities from activation to study closure.
• Manage budgeting, payments, and local regulatory submissions.
• Ensure documentation in CTMS and country-level eTMF readiness.
• Coordinate audits, training, and risk management at country level.

Skills

Cross-functional leadership

Project management

Team building

Organizational skills

Communication skills

Prioritization

Attention to detail

English fluency

Education

Bachelor’s degree in life science

Tools

CTMS

Regulatory systems

Job description

Parexel is seeking a Local Study Associate Director (LSAD) for a remote role in the US. Oncology experience required; cell therapy preferred. Leads Local Study Team to deliver study components within budget and timelines, ensuring compliance with ICH-GCP and local regulations.

The LSAD may perform site monitoring, coordinate site selection, and oversee CTMS and eTMF activities, while managing risks and patient recruitment strategies across country sites.