Description
Syneos Health is seeking a Medical Specialist to join their Clinical Solutions team. As a Medical Specialist, you will perform Trial Master File (TMF) filing of study-specific medical documents and relevant medical communications, assist with eligibility review and project management activities, and support medical review query management and other medical data review tasks.
Core Responsibilities
- Performs Trial Master File (TMF) filing of study-specific medical documents and relevant medical communications; may participate in TMF file audits.
- Assists 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.
- Supports medical review query management and other medical data review tasks as needed.
- Manages the shared mailbox and routes correspondence appropriately.
- Assists with coordination of medical management project meetings, attends meetings, prepares meeting minutes and action items, and maintains study-related documents.
- Uploads and manages documents collected for eligibility review into TrialEAS and other eligibility review support systems as needed.
- Adheres 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.
Additional Qualifications
- 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.
- 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.
- 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.