Senior Study Specialist

Desired Skills: clinical study management,clinical trials,TMF. etmf,CTMS,CRO,pharmaceutical,IRB submissions

PE Global is currently recruiting for a Senior Study Specialist on behalf of a leading global biotechnology organisation on an initial 6 month contract basis.

Contract duration: 6 months

Location: London (hybrid)

Rate: £206.06 per day PAYE

Role Overview

The Senior Study Specialist plays a key role in the delivery of clinical studies, contributing to or leading activities across site monitoring oversight, vendor management, and study execution. Working closely with the Study Manager or Program Lead, you will help ensure studies are delivered to the highest standards of quality, compliance, and patient safety, while meeting timelines and budget expectations.

Key Responsibilities

• Develop and maintain study-specific documentation in collaboration with study leadership
• Support country/site feasibility and site selection activities
• Oversee CRO activities related to IRB/EC submissions and approvals
• Manage essential documents across the study lifecycle, including TMF oversight
• Coordinate and oversee investigator/site training materials and presentations
• Present at investigator meetings as required
• Ensure timely and accurate updates to ClinicalTrials.gov
• Support screening authorisation processes and tracking
• Manage document workflows via DocuSign
• Oversee clinical trial insurance processes
• Represent Global Study Operations in cross-functional and vendor meetings
• Identify study risks and contribute to mitigation strategies
• Provide operational and administrative support for internal/external meetings

Candidate Requirements

• Bachelor’s degree (or higher) in Nursing, Life Sciences, or a related field (or equivalent experience)
• Proven experience within a biotech or pharmaceutical environment
• Hands-on experience managing external vendors (e.g., CROs, central labs, imaging providers)
• Strong understanding of budgets, SOWs, purchase orders, and invoice management
• Ability to manage multiple priorities in a fast-paced, global environment
• Compliance, quality, and regulatory understanding
• Drug development lifecycle and study design
• Clinical study management and execution

Interested candidates should submit an updated CV.

Please click the link below to apply or email a copy of your CV to karen@peglobal.co.uk or for more information call +442081491060

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in the United Kingdom***