
10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
🔥 26 minutes ago
🇺🇸 United States – Remote
⏰ Full Time
🟡 Mid-level
🟠 Senior
🧪 Clinical Research
🦅 H1B Visa Sponsor
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10,000+ employees
🏥 Healthcare
💼 Consulting
📦 Logistics
Healthcare • Consulting • Logistics
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.
• Develop medical plans with the Medical Director and coordinate necessary 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 data patterns/trends and document medical reviews • Author medical data queries, review responses, and approve query closure with the Medical Director • Assist with patient profile reviews, scientific reviews 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 the 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 to identify data integrity and subject safety risks • Escalate study concerns, at-risk deliverables, and out-of-scope tasks to project leads • Attend Trusted Process meetings and participate in internal and external audits • Adhere to data privacy guidelines, ICH, GCPs, enterprise policies, SOPs, work instructions, project plans, and customer requirements
• Ability to develop medical plans with the Medical Director, including Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan • Ability to perform medical review of data listings and data visualization and identify risks and data patterns/trends • Ability to author medical data queries, review query responses, and approve query closure in association with the Medical Director • Ability to assist with patient profile review, scientific review of study-level data, protocol deviation review, and Medical Review Summary reports • Ability to prepare slides for medical data review and safety review meetings • Knowledge of ongoing protocol designs and disease-related terminology and pathology • Knowledge of data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs) • Ability to follow enterprise, customer, project, standard operating procedure, and work instruction requirements • Equivalent experience, skills, and/or education will also be considered
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance • 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
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