
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.
🔥 0 minutes ago
🇺🇸 United States – Remote
💵 $67.7k - $115.1k / year
⏰ Full Time
🟡 Mid-level
🟠 Senior
🦅 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.
• Work with the Medical Director to develop the Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan • Engage outside experts, consultants, and advisors to coordinate necessary medical/scientific input • Perform regular and ad-hoc medical review of data listings and data visualizations • Analyze data to identify risks and data patterns/trends and document medical reviews • Proactively 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 review, 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 study team members to identify risks related to data integrity and subject safety • 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 • Adhere to data privacy guidelines, ICH, GCPs, policies, SOPs, work instructions, and project plans • May manage a limited number of direct reports and participate in or conduct interviews
• Experience and deep expertise in clinical solutions, medical monitoring, or related areas • Basic understanding and knowledge of ongoing protocol designs • Knowledge of disease-related terminology and pathology • Knowledge of International Committee on Harmonization (ICH) guidelines • Knowledge of Good Clinical Practices (GCPs) • Adherence to data privacy guidelines, enterprise policies, standard operating procedures, work instructions, and project plans • Ability to perform medical review of data listings and data visualizations • Ability to analyze data to identify risks and data patterns/trends • Ability to author medical data queries and review query responses • Ability to collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management • Ability to attend and present at Trusted Process meetings • Ability to participate in internal and external audits • Equivalent experience, skills, and/or education may 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) • Sick time
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