Company Overview
We are supporting a late clinical stage biopharmaceutical company advancing a first-in-class treatment of serious metabolic liver disease. Their lead programme is entering Phase 3, a significant inflection point for both the asset and the organisation.
This is a rare opportunity to join a focused, high-calibre team at the moment it matters most: building the clinical infrastructure to take a differentiated therapy through a pivotal global trial. You will have real ownership, direct senior access, and the chance to shape how they operate.
THE ROLE
As Senior/Clinical Trial Manager, you will own end-to-end execution of one or more Phase 3 studies. You will be the primary operational lead on the sponsor side, managing CROs, vendors, investigative sites, and cross-functional teams across the US and Europe. The role reports directly to Senior Leadership.
For the Senior CTM level, you will additionally take accountability for functional leadership, mentoring junior clinical operations staff, and contributing to process and system development as we scale.
WHAT YOU’LL DO
* Lead the creation and management of study project plans timelines, budgets, resourcing, and vendor coordination from concept through final CSR
* Serve as the primary sponsor-side operational lead for CRO oversight, including governance cadence, KPI tracking, and performance management
* Ensure all trials are conducted in compliance with ICH-GCP, FDA, EMA, MHRA, and applicable local regulations across multiple jurisdictions
* Drive proactive risk identification and mitigation owning the risk register and escalating appropriately to the medical monitor and VP
* Manage IP logistics, clinical lab samples, and ancillary supply shipments across US and European sites
* Review SAEs and pertinent safety data with the medical monitor and drug safety team to identify trends and signals
* Ensure ongoing compilation, organisation, and reconciliation of the Trial Master File
* Lead or participate in investigative site meetings, KOL interactions, and vendor selection activities
* Mentor and develop junior clinical operations personnel (Senior CTM level)
* Participate in process improvement and operational scaling initiatives as the organisation grows
WHAT WE’RE LOOKING FOR
* 8+ years of clinical research experience in an industry (sponsor-side) setting
* Minimum 3 years as a project lead or trial manager, with clear ownership of Phase 2/3 trial execution
* Direct experience managing global trials with US and European sites practical knowledge of EMA, MHRA, and national competent authority processes
* Proven CRO management track record: governance, SLAs, performance escalation
* Strong working knowledge of GCP, ICH guidelines, and multi-jurisdictional regulatory requirements
* Experience with TMF management, budget tracking, and trial tools (SmartSheet, MS Project, Veeva, Medidata or similar)
* Therapeutic area experience in metabolic disease, hepatology, GI, or cardiometabolic strongly preferred