
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
🏈 Alabama, Arizona, +36 more states – Remote
💵 $67.7k - $115.1k / year
⏰ 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.
• Work with the Medical Director to develop medical plans • Engage outside experts, consultants, and advisors to obtain medical/scientific input • Perform regular and ad-hoc medical review of data listings and visualizations • Analyze data to identify risks and data patterns/trends • Document medical reviews and proactively 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 study-level data reviews, 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 study team members to identify risks related to data integrity and subject safety • Escalate project concerns, at-risk deliverables, and out-of-scope tasks to project leads • Attend and present at Trusted Process meetings • Participate in internal and external audits • Adhere to data privacy, ICH, GCP, company, customer, SOP, work instruction, and project plan requirements
• Clinical/medical scientist experience in medical monitoring, oncology, and Phase I studies • Ability to develop Medical Management Plans, Medical Data Review Plans, and Eligibility Review Plans • Experience performing medical review of data listings and data visualizations • Ability to analyze data for risks and patterns/trends • Ability to author medical data queries and review query responses • Knowledge of patient profile review, scientific study-level data review, protocol deviation review, and Medical Review Summary reports • Ability to prepare slides for medical data review and safety review meetings • Ability to manage project scope, objectives, deliverables, milestones, and timelines • Ability to collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management • Basic understanding of protocol designs, disease-related terminology, and pathology • Knowledge of data privacy guidelines, ICH, GCPs, enterprise policies, SOPs, work instructions, and project plans • 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) • Sick time
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