Senior Local Trials Operations Lead – Hem/Onc

Regulatory Jobs

Center Square (PA)

On-site

USD 120,000 - 150,000

Full time

4 days ago
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Benefits offered by this job

Health coverage
Retirement plans
Life assurance and disability
Employee assistance and wellbeing
Learning and development opportunities

Job summary

ICON Strategic Solutions seeks a Senior Local Operations Manager in HemOnc to streamline cross-functional communication across trial lifecycles. You will act as the main liaison for sites and client teams, ensuring recruitment targets, quality data, and compliant operations across country trials.

You will manage local procedures, budgets, and vendor interactions, driving CAPA and QA activities while maintaining inspection readiness and country-specific informed consent processes.

Qualifications

  • BA/BS degree required with science/health focus or related field.
  • HemOnc trial management experience is required.
  • 3–5+ years end-to-end trial management experience in a sponsor/ CRO setting.
  • Strong knowledge of ICH-GCP, SOPs, and regulatory requirements.

Responsibilities

  • Serve as the primary communication point for sites and internal teams.
  • Own site relationships and ensure timely patient recruitment and data quality.
  • Maintain trial management systems and generate reports for oversight.
  • Lead local startup activities, budgets, and contingency planning.
  • Ensure regulatory and CAPA processes to support inspections.

Skills

Stakeholder management
English proficiency
ICH-GCP knowledge
Project coordination
Budget forecasting

Education

BA/BS degree
Health or science background

Tools

CTMS
eTMF

Job description

ICON Strategic Solutions seeks a Senior Local Operations Manager in HemOnc to streamline cross-functional communication across trial lifecycles. You will act as the main liaison for sites and client teams, ensuring recruitment targets, quality data, and compliant operations across country trials.

You will manage local procedures, budgets, and vendor interactions, driving CAPA and QA activities while maintaining inspection readiness and country-specific informed consent processes.

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