Medical Monitor

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Oversee medical aspects of one or more assigned clinical trials within a program or portfolio.

• Ensure the safety of patients and adherence to protocols throughout the trial process.

• Utilize medical expertise to address eligibility inquiries, protocol deviations, dosing choices, and risk mitigation for participants.

• Evaluate and review Adverse Events (AEs) and Serious Adverse Events (SAEs), including assessments of causality and severity.

• Engage in ongoing safety evaluations, participate in internal safety committees, and attend Data Safety Monitoring Boards as necessary.

• Work in collaboration with Pharmacovigilance to identify safety signals, escalate concerns, and implement risk-management strategies.

• Assist in protocol amendments or safety measures when warranted.

• Act as a primary medical liaison for investigators and respond to protocol-specific medical inquiries.

• Contribute to investigator meetings and site engagement activities by providing study-specific medical insights.

• Supervise studies conducted with Contract Research Organization (CRO) medical monitors.

• Work collaboratively with Clinical Trial Leads, Clinical Project Managers, Clinical Research Associates (CRAs), Data Management, and Biostatistics teams.

• Participate in operational safety and study management discussions.

• Identify and address safety or operational risks that may impact study execution.

• Contribute to the preparation of clinical study reports, safety narratives, and documents for regulatory submissions.

• Ensure the accuracy and consistency of medical data in study documentation and regulatory materials.

• Facilitate regulatory interactions by addressing questions related to clinical execution and safety.

• Ensure alignment and reconciliation of Serious Adverse Events (SAEs) among clinical, safety, and regulatory datasets.

⛳️ Requirements

• MD or equivalent medical qualification.

• 3–7 years of experience in executing clinical trials, performing medical monitoring, or in similar positions.

• In-depth knowledge of Good Clinical Practice (GCP), clinical trial execution, and safety reporting mandates.

• Experience in reviewing AEs and SAEs and participating in safety oversight processes.

• Capability to operate within protocol and regulatory frameworks while exercising sound medical judgment.

• Strong clinical judgment with a focus on patient safety and data integrity.

• Comprehensive understanding of clinical trial methodologies and operational execution.

• Ability to work effectively within cross-functional and matrixed teams.

• Excellent and professional communication skills with investigators and study stakeholders.

• Detail-oriented with a robust documentation and compliance mindset.

🏝️ Benefits

• Relocation assistance is not available.