Study Operations Specialist
hace 4 semanas
Role Overview
We are seeking a Study Operations Specialist to join our team at ENGINEERINGUK. As a Clinical Trial Manager, you will be responsible for overseeing the execution of clinical studies in accordance with our global program strategy.
Key Responsibilities:
- Planning and Management: Lead the cross-functional Local Study Team (LST) to plan, manage, and oversee clinical study execution.
- Study Execution: Contribute to program/study-specific materials, such as monitoring plans and training documents.
- Site-Level Goal Setting: Accountable for site-level goal setting and study-specific deliverables for clinical sites within your country/ies.
- Training and Development: Contribute to, deliver, and/or lead CRA, Investigator, and Study Coordinator training.
- Vendor Oversight: Provide oversight and monitoring of applicable vendor activities, such as laboratories and equipment provisioning.
- Country Operational Plan: Provide country-level input into the Country Operational Plan (COP) and partner with the DFM to ensure local delivery of the study.
- Baseline and Revised Enrolment Plans: Responsible for approval of Baseline and Revised Enrolment Plans (Country Level).
- Study Monitoring: Monitor the execution of the clinical study against timelines, deliverables, and budget for that country.
- Data Flow Metrics: Translate global start-up requirements into local country targets and monitor data flow metrics, reviewing trends and analysis, with targeted follow-up where appropriate.
- Risk Identification and Mitigation: Identify and facilitate resolution of cross-functional study-specific issues and escalate any issues related to delivery, timelines, or budget to GCMs (or TMT lead if appropriate).
- Regulatory Agency Inspection Readiness: Execute regulatory agency inspection readiness activities, such as TMF review and story board generation.
About You
We are looking for a highly skilled and experienced individual with a Bachelor's degree in a health, life sciences, or other relevant field of study. A minimum of 5-6 years' work experience in clinical research or project management and site management is required, with CRA experience preferred.
What We Offer
In addition to your competitive salary of approximately £60,000 - £80,000 per annum, depending on location, we offer a range of benefits focused on well-being and work-life balance opportunities for you and your family. Our diverse culture rewards high performance and nurtures talent, making us an attractive employer in the industry.
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