Senior Clinical Trials Lead: Site Management & Compliance

Parexel; Uxbridge; Hybrid; GBP 38,000 - 52,000; Full time

Job summary

Parexel is seeking an experienced Clinical Research Associate to support investigator/site selection, monitoring activities, and regulatory start-up tasks. You will train site staff, ensure training is documented, and maintain inspection readiness across multiple sites.

Your role includes on-going monitoring (remote and on-site), SDR/CRF review, data verification, and QA compliance, with regular collaboration with LSAD, CQAD and MSLs. Travel will be required.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Excellent knowledge of international guidelines ICH-GCP and GMP/GDP basics.
• Good knowledge of local regulations and drug development processes.
• Strong understanding of Clinical Study Management incl. monitoring and data management.

Responsibilities

• Contributes to investigator/site selection and start-up activities.
• Trains and supports Investigators and site staff on study matters.
• Ensures training is completed and sites are inspection ready.
• Performs monitoring visits (remote/onsite) and data checks per plan.
• Performs SDR/CRF review and SDV per Monitoring Plan.
• Maintains ISF, drug accountability, and eTMF documents.
• Prepares monitoring visit reports and follow-up letters.
• Collaborates with LSAD, CQAD and Medical Liaisons as directed.
• Ensures timely reporting of Serious Adverse Events and site progress.
• Travels nationally/internationally as required.

Skills

Attention to detail

Written & verbal English

Communication

Team player

Education

Bachelor’s degree in life sciences

Tools

CTMS

Job description

Parexel is seeking an experienced Clinical Research Associate to support investigator/site selection, monitoring activities, and regulatory start-up tasks. You will train site staff, ensure training is documented, and maintain inspection readiness across multiple sites.

Your role includes on-going monitoring (remote and on-site), SDR/CRF review, data verification, and QA compliance, with regular collaboration with LSAD, CQAD and MSLs. Travel will be required.