Contract Medical Monitor

AL SolutionsUnited States
ContractOn-siteExecutiveLimited info disclosed
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Description

Contract Medical Director / Medical Monitor – Spinal Cord Injury Study Location: Remote Contract Type: Contract 0.5-1.0 FTE (depending on availability) Therapeutic Area: Spinal Cord Injury / Neurology / Rehabilitation Medicine AL Solutions is supporting a clinical-stage biotech with the appointment of a contract Medical Director / Medical Monitor to provide sponsor-side medical oversight for a Spinal Cord Injury clinical study. This is an excellent opportunity for a physician with clinical development and medical monitoring experience to support an innovative biotech programme within a highly specialised therapeutic area. The successful candidate will act as the sponsor Medical Monitor and provide medical leadership across study start-up, conduct, data review, safety oversight, analysis, reporting and regulatory submission readiness. Key Responsibilities Provide sponsor-side medical oversight for a Spinal Cord Injury clinical study Act as the Medical Monitor for the study, supporting patient safety, protocol compliance and scientific integrity Provide medical input across study start-up, study conduct, data review, analysis, reporting and regulatory submission preparation Oversee CRO medical monitoring activities and ensure appropriate escalation of medical and safety-related issues Partner closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Safety, Quality and external vendors Review clinical data, safety data, protocol deviations and medical queries as required Support protocol interpretation and provide medical guidance to study sites, CRO teams and internal stakeholders Contribute to clinical study reports, regulatory documents and other clinical development deliverables Ensure the study is conducted in accordance with GCP, ICH E6(R3), protocol requirements and applicable regulatory standards Required Experience Medical Doctor qualification Active medical licence to practise in the US and/or Canada Previous experience as a Medical Monitor or sponsor-side clinical development physician Strong understanding of clinical trial conduct, GCP, ICH guidelines and regulatory expectations Experience overseeing CRO medical monitoring activities Ability to work cross-functionally with Clinical Operations, Safety, Regulatory, Data Management, Biostatistics and Quality teams Strong communication skills and the ability to provide clear medical guidance across internal and external study teams Preferred Background Experience in one or more of the following areas would be highly relevant: Physical Medicine & Rehabilitation Neurology Neurosurgery Internal Medicine Spinal Cord Injury studies Neurological or rehabilitation-focused clinical development programmes Please note, US training is not required, provided the candidate holds an active medical licence to practise in the US and/or Canada. Apply Please reach out directly if this opportunity is relevant to your experience, or if you would like to discuss the role in more detail. alexander@alsolutions.co.uk Show more Show less