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Study Monitoring Lead

United States
GBP 150000 - 170000.0000000000

Study Monitoring Lead
Department: Global Clinical Operations

Position Summary
The Study Monitoring Lead is responsible for the operational oversight of global clinical trials, ensuring studies are executed in accordance with protocol, timelines, ICH-GCP, regulatory requirements, and company SOPs. The SML oversees study feasibility, site management, monitoring activities, and CRO/vendor performance while partnering with cross-functional teams to drive successful study execution.

Responsibilities

  • Lead study feasibility activities, evaluating country and site capabilities, patient access, and operational readiness.

  • Partner with the Clinical Study Manager, Clinical Study Physician, and CROs to support country and site selection.

  • Oversee site activation activities, including regulatory documentation, contracts, investigational product supply, laboratory kits, and other start-up requirements.

  • Monitor site activation, enrollment, protocol compliance, and data quality.

  • Prepare, review, or approve Monitoring Plans, Laboratory Manuals, patient-facing materials, and other operational study documents.

  • Oversee CRO and vendor performance related to site management and monitoring.

  • Support training for CRO Clinical Trial Leads, CRAs, and investigative sites.

  • Oversee remote and on-site monitoring activities, ensuring timely visit completion, issue resolution, and follow-up.

  • Conduct sponsor co-monitoring visits and perform monitoring or co-monitoring activities as needed.

  • Track study metrics, including site activation, enrollment, monitoring visits, protocol deviations, and overall study progress.

  • Oversee biological sample tracking and investigational product management with study stakeholders.

  • Collaborate with Clinical Operations, Data Management, Medical, Safety, Regulatory, Clinical Supply, CROs, vendors, investigators, and study sites to ensure efficient study execution.

  • Identify and resolve operational risks, escalating issues when appropriate.

  • Ensure compliance with study protocols, ICH-GCP, regulatory requirements, and company SOPs while supporting inspection readiness.

Qualifications

  • Master's degree in Life Sciences or a related field.

  • 5+ years of clinical operations experience, including 3+ years monitoring oncology studies as a CRA or comparable site management role.

  • Experience with study feasibility, site selection, site activation, monitoring oversight, and CRO/vendor management.

  • Strong knowledge of ICH-GCP, global clinical trial regulations, and inspection readiness.

  • Excellent communication, collaboration, organizational, analytical, and problem-solving skills.

  • Ability to travel internationally as required.

Apply Now

Discipline

Pharma

Job Ref

PR/030333

Published

1 day ago

Expiry

30 Jul 2026 23:59

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