Expanded Access - Project Manager
JOB_53714434766722Job type
ContractLocation
LondonWorking Pattern
Full-timeSpecialism
Clinical ResearchIndustry
Scientific and R&DPay
Day Rate
Exp Clin Project Manager must have previous experience in Expanded Access prog - 6-month initial contract (
Global Bio Pharma, looking for an experienced Clinical Project Manager - 6 month initial contract, (out of scope) hybrid
The Global Managed Access Project Manager is responsible for leading the strategy, planning, and execution of Managed Access and Early Access programs at the global level. The role ensures compliant, timely, and patient‑focused access to investigational or unlicensed medicines outside of clinical trials, working closely with cross‑functional teams and external partners.
The Global Managed Access Project Manager is responsible for leading the strategy, planning, and execution of Managed Access and Early Access programs at the global level. The role ensures compliant, timely, and patient‑focused access to investigational or unlicensed medicines outside of clinical trials, working closely with cross‑functional teams and external partners.
The position requires coordination of Managed Access strategy for each new product or indication, including development assets, in‑licensed products, and acquisitions. It involves engaging internal stakeholders such as Medical Affairs, Regulatory, Pharmacovigilance, Market Access, Legal, Supply Chain, Quality, Ethics, Commercial, and Distribution teams to ensure strategic alignment and operational feasibility.
The role contributes to designing operational aspects of Managed Access programs and developing key program documentation, including access request forms, order forms, informed consent forms, and healthcare provider responsibility documents. These materials must meet internal standards, ethical requirements, and global regulatory expectations.
The Project Manager leads global program execution from initiation to closure, maintaining oversight of timelines, budgets, risks, and deliverables, and ensuring transparent communication with global and affiliate stakeholders. The role coordinates cross‑functional input, resolves issues proactively, and provides regular status updates to ensure alignment across teams.
Vendor-related responsibilities include managing procurement activities for global Managed Access partners, conducting evaluations, leading contracting processes, and ensuring ongoing operational oversight. The role monitors vendor performance, ensures adherence to service agreements, and escalates issues where needed to safeguard program quality and patient safety.
Documentation governance is a critical part of the role, requiring diligent maintenance of program records in the electronic Document Management System. This includes monthly status updates, regular quality reviews, ensuring completeness of documentation, and maintaining audit‑ready files throughout the program lifecycle and at closure.
The position also provides support to internal audit and inspection activities, contributing evidence, documentation, and process expertise as required. Corrective and preventive actions may be supported following inspections or quality reviews.
The Project Manager offers operational guidance to affiliates conducting local Managed Access activities and supports training of internal staff on product access request processes. The role also contributes to continuous improvement by enhancing processes, templates, tools, and documentation across global Managed Access operations.
Essential experience includes strong knowledge of clinical operations, regulatory processes, or medical affairs within the biopharmaceutical industry, along with familiarity with global Managed Access or Early Access pathways. The role requires proven ability to manage complex global projects, work with vendors, and maintain excellence in compliance and documentation. Preferred experience includes oncology or rare disease expertise, quality management, and audit support.
The position requires strong project management capability, cross‑functional collaboration, vendor management, documentation accuracy, effective communication, problem solving, and a patient‑centric mindset.
You must be based in the UK, with UK experience, Hybrid role
Please send CV to Claire.helliwell@hays.com
Expanded Access - Project ManagerJOB_537144347667222026-01-302026-05-01
Talk to Claire Helliwell, the specialist consultant managing this position
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JOB_53714434766722