
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.
🔥 18 hours ago
🗽 New York – 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 Medical Management, Medical Data Review, and Eligibility Review Plans • Engage outside experts, consultants, and advisors to coordinate medical/scientific input for medical plans • Perform regular and ad-hoc medical review of data listings and data visualization • Analyze data to identify risks and data 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 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 between internal teams, customers, and vendors for medical data review 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, enterprise policies, SOPs, work instructions, and project plans • Manage a limited number of direct reports and participate in or conduct interviews
• Experience and deep expertise in clinical/medical science and drug development • Basic understanding and knowledge of ongoing protocol designs • Basic understanding of disease-related terminology and pathology • Knowledge of medical data review and eligibility review • Knowledge of data listings and data visualization • Ability to analyze data to identify risks and data patterns/trends • Knowledge of International Committee on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs) • Ability to adhere to data privacy guidelines, enterprise policies, standard operating procedures, work instructions, and project plans • Ability to collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management • Ability to participate in or conduct interviews • Equivalent experience, skills, and/or education will be considered
• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • 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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