Medical Specialist

Overview

Performs Trial Master File filing and supports medical management and scientific services staff with eligibility review, medical data review and project coordination for clinical studies.

What you'll do

• Perform Trial Master File (TMF) filing of study-specific medical documents and relevant medical communications; may participate in TMF file audits.
• Assist Medical Management and Scientific Services staff with eligibility review and project management activities, including development of eligibility review forms and other study-related documents as needed.
• Support medical review query management and other medical data review tasks as needed.
• Manage the shared mailbox and route correspondence appropriately.
• Assist with coordination of medical management project meetings, attend meetings, prepare meeting minutes and action items, and maintain study-related documents.
• Upload and manage documents collected for eligibility review into TrialEAS and other eligibility review support systems as needed.
• Adhere to all data privacy guidelines, International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) requirements, enterprise policies, standard operating procedures, work instructions, and project plans.
• Adhere to customer policies and standard operating procedures as required in project plans.

What you'll need

• Postgraduate in biological sciences or a related natural sciences/healthcare discipline, nursing degree, or equivalent combination of education and experience is essential.
• Solid office/administrative experience.
• Advanced proficiency in Microsoft Office Suite, including Word, Excel and PowerPoint.
• Strong customer service skills with effective written and verbal communication appropriate to a professional medical setting.
• Strong organisational, presentation, documentation and interpersonal skills, with a team-oriented approach.
• Ability to multitask and meet tight deadlines in a dynamic environment while maintaining attention to detail and high-quality work.

Nice to have

• Previous 1–2 years of clinical research experience, such as CTA or study coordinator, is preferred but not mandatory.
• Knowledge of protocol- and disease-related terminology and the drug development process, including databases and medical terminology, would be an advantage.