
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.
🔥 22 hours ago
🌐 United States, Canada – Remote
🏈 Alabama – Remote
💵 $80.6k - $145k / year
⏰ Full Time
🟠 Senior
🔴 Lead
🔍🏥 Medical Reviewer
🦅 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.
• Perform clinical review ahead of significant project milestones, including interim analysis, study closeout, and submission • Ensure data readiness for interim and final analyses, submission snapshots, Data Monitoring Committee reviews, and publications • Review participant-level data across studies according to CRF Completion Guidelines and the Data Review Plan • Conduct point-to-point data checks and interpretive analysis to identify inconsistencies • Generate queries on discrepant data and follow them through resolution, escalating unresolved issues • Create and use data review best practices and tools to identify trends and safety signals • Identify and escalate protocol deviations during routine clinical review • Follow applicable SOPs, regulations, and training requirements while improving clinical procedure quality and efficiency • Liaise with data management, clinical and site management, and other study team members • Attend clinical meetings and study meetings
• Sr CRA or CTM experience with Oncology is required • Candidates must reside in US or Canada with no sponsorship needs • Bachelor’s degree or nursing degree is preferred • At least 7 years of clinical research experience in the pharmaceutical industry • Strong monitoring experience is a plus • Direct clinical review and query writing/resolution experience required • Sufficient clinical knowledge to assess whether participant data is scientifically and clinically valid • Prior EDC experience preferred • Proficient in reviewing large-scale listings in Microsoft Excel format, including filtering, sorting, and date formatting • Basic understanding of how data points from different fields/CRFs interact and how data collection impacts analysis • Ability to work independently in a virtual setting and as part of a remote team • Ability to prioritize and adjust work priorities quickly to meet deadlines • Basic knowledge of data management, including case report form design, electronic edit checks, data handling conventions, and data status reports • Good written and oral communication skills with strong attention to detail
• 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 • Reasonable accommodations for applicants and employees with disabilities
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