Remote Local Study Director – Oncology Trials

Parexel; Trenton (NJ); Remote; USD 110,000 - 160,000; Full time

Job summary

Parexel is seeking Local Study Associate Directors (LSAD) for a remote US role. Oncology experience is required; cell therapy experience is strongly preferred.

The LSAD leads Local Study Team(s) to deliver study components, ensure regulatory compliance, and manage site feasibility, qualification, initiation, monitoring, and closure across country level operations. The LSAD coordinates site selection, CTMS setup, and audits in alignment with ICH-GCP and local regulations, while supporting

Qualifications

• Minimum 3 years in Development Operations (CRA, SrCRA) or related fields.
• Good knowledge of ICH-GCP and local regulations.
• Proven ability to lead cross functional teams.

Responsibilities

• Lead Local Study Team(s) at country level to deliver study components on time and within budget.
• Coordinate site selection, Site Qualification Visits and risk assessments.
• Oversee CTMS setup and local website requirements; manage monitoring through study closure.
• Ensure regulatory submissions, documentation archiving and audit readiness.
• Forecast timelines, resources, recruitment and budget; communicate with stakeholders.

Skills

Cross-functional leadership

Project management

Team building

Organizational skills

Verbal and written communication

English fluency

Education

Bachelor's degree in life sciences

Job description

Parexel is seeking Local Study Associate Directors (LSAD) for a remote US role. Oncology experience is required; cell therapy experience is strongly preferred.

The LSAD leads Local Study Team(s) to deliver study components, ensure regulatory compliance, and manage site feasibility, qualification, initiation, monitoring, and closure across country level operations. The LSAD coordinates site selection, CTMS setup, and audits in alignment with ICH-GCP and local regulations, while supporting