Principal Medical Scientist (Project Lead) - RWE

About the role

Syneos Health is hiring a Principal Medical Scientist (Project Lead) for Real-World Evidence (RWE) projects, working remotely for clients in Poland, Bulgaria, Romania, Spain and the UK. The role is sponsor-dedicated and acts as the key scientific leader on the customer partnership, portfolio or coalition level.

Key responsibilities

• Manage project scope, objectives and quality of deliverables so that milestones and timelines are met
• Act as main interface between internal team, customers and vendors on medical monitoring, medical data review, eligibility review and other medical services
• Work with Medical Directors to develop medical plans (medical management, data review and eligibility review plans) and with customers on non-standard procedures and project plans
• Perform regular and ad-hoc medical review of data listings and visualizations, analyze data for risks and trends, and provide advanced medical data review
• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance and Project Management to identify risks to data integrity and subject safety, and escalate study concerns
• Lead the Scientific Services team on a project, evaluate resourcing needs and act as Subject Matter Expert
• Provide scientific oversight and training to staff and project teams, attend Trusted Process meetings and support responses to audit or inspection findings
• Assist Medical Directors with training materials and documents such as clinical protocols, study reports, abstracts, presentations and investigator brochures
• Develop or oversee work orders and change orders for projects involving MSM, contribute to business development and RFPs, and advise on data collection tools and monitoring plans
• Evaluate processes for improvement and adhere to ICH, GCPs, data privacy guidelines and customer SOPs

Required profile

• BA/BS degree in life sciences or health-related field with 5+ years of practical experience, or MS/MBA with 3+ years, PharmD/PhD with 2 years, or MD/DO with 1 year
• Industry experience in a Clinical Scientist role or similar
• Experience on multinational teams and studies, and hands-on experience in epidemiology study design, conduct and analysis
• Experience in or leading study teams, and working independently with multiple functional groups
• Ability to apply consistent medical/scientific concepts across multiple studies
• Independent authorship of study protocols and other study documents
• Experience managing external vendors for clinical and/or epidemiological studies

Required skills

• Strong knowledge of the clinical research process, GCPs, monitoring, clinical and regulatory operations
• Working knowledge of statistics, data analysis and data interpretation
• Knowledge of epidemiology study design, conduct and analysis