Clinical Medical Scientist – Medical Monitoring, Infectious Disease
Posted 30ds ago
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Job Description
Medical Scientist supporting HIV clinical-trial medical monitoring at Syneos Health, a biopharmaceutical solutions organization. Reviewing medical data, managing risks, and coordinating cross-functional study teams.
Responsibilities:
- Develop medical plans with the Medical Director, including Medical Management, Medical Data Review, and Eligibility Review Plans
- Coordinate acquisition of medical/scientific input from outside experts, consultants, and advisors
- Perform regular and ad-hoc medical review of data listings and visualizations
- Analyze data to identify risks and patterns/trends and document medical reviews
- Identify and resolve medical data review issues
- Author medical data queries, review responses, and approve query closure with the Medical Director
- Assist with patient profile reviews, scientific review of study-level data, protocol deviation reviews, and Medical Review Summary reports
- Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
- Manage project scope, objectives, deliverable quality, milestones, and timelines
- Serve as primary interface among internal teams, customers, and vendors for medical data and eligibility review
- Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams to identify data integrity and subject safety risks
- Escalate study concerns, at-risk deliverables, and out-of-scope tasks to project leads
- Attend and present at Trusted Process meetings and participate in internal and external audits
- Maintain understanding of protocol designs, disease terminology, and pathology
- Follow data privacy guidelines, ICH, GCPs, company policies, SOPs, work instructions, and project plans
Requirements:
- Degree in life sciences (BS, MSc, PharmD, PhD)
- Medical monitoring experience in HIV clinical trials required
- Excellent time management skills to handle multiple tasks and meet deadlines in a highly regulated and dynamic environment
- Self-starter comfortable with fluctuating timelines, work demands, and changes in scope of work
- Ability to troubleshoot situations and escalate issues or questions when needed
- Understanding of scientific principles for effective, high-quality medical data analysis
- Excellent written and oral communication skills
- Excellent computer skills, including MS Office programs, spreadsheets, and presentations
- Knowledge of drug development and demonstrated proficiency with ICH/GCP guidelines
- Strong interpersonal skills and ability to work effectively in a cross-functional team environment
- May travel up to 25%
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO) and sick time
- Company car or car allowance may be included
