Remote Local Study Director - Oncology Trials & Cell Therapy

Parexel; Lincoln (NE); Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a Local Study Associate Director (LSAD) for a remote role in the United States. The LSAD leads Local Study Team(s) at the country level to deliver study components within budget and timelines, ensuring compliance with ICH-GCP and local regulations, and may perform site monitoring as needed.

The role requires oncology experience, with cell therapy strongly preferred, and involves managing site qualification, CTMS setup, monitoring oversight, and collaboration with national and

Qualifications

• Minimum 3 years of experience in Development Operations (CRA, SrCRA) or related fields.
• Proven ability to lead cross-functional teams and deliver clinical trials on time and within budget.
• Strong knowledge of ICH-GCP and local regulations.

Responsibilities

• Leads Local Study Team(s) at country level and ensures timely study delivery.
• Oversees monitoring activities from site activation through closure in line with Monitoring Plans.
• Manages site selection, Site Qualification Visits and Site Quality Risk Assessments.
• Coordinates regulatory submissions and documentation to ensure inspection readiness.
• Maintains CTMS and local websites per local laws and regulations.
• Forecasts timelines, resources, recruitment, budget, and study materials.
• Conducts training and coaching for new Local Study Team members on ICH-GCP and SOPs.
• Plans and leads National Investigator meetings and communicates with investigators.
• Participates in audits and regulatory inspections in liaison with QA.

Skills

Leadership

Project management

Cross-functional leadership

ICH-GCP knowledge

Regulatory knowledge

English

Budgeting

CTMS

Monitoring

Communication

Education

Bachelor’s degree in life sciences

Tools

CTMS

eTMF

Job description

Parexel is seeking a Local Study Associate Director (LSAD) for a remote role in the United States. The LSAD leads Local Study Team(s) at the country level to deliver study components within budget and timelines, ensuring compliance with ICH-GCP and local regulations, and may perform site monitoring as needed.

The role requires oncology experience, with cell therapy strongly preferred, and involves managing site qualification, CTMS setup, monitoring oversight, and collaboration with national and