Senior Medical Scientist – Infectious Disease, HIV

🔥 0 minutes ago

🏈 Alabama, Arizona, +39 more states – Remote

🏈 Alabama – Remote 🌵 Arizona – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🐊 Florida – Remote 🥔 Idaho – Remote 🌽 Illinois – Remote 🌾 Iowa – Remote 🌪️ Kansas – Remote 🐎 Kentucky – Remote ⚜️ Louisiana – Remote 🦞 Maine – Remote 🦬 Montana – Remote 🌾 Nebraska – Remote 🎰 Nevada – Remote 🗻 New Hampshire – Remote 🏖️ New Jersey – Remote 🌶️ New Mexico – Remote 🗽 New York – Remote 🌲 North Carolina – Remote 🌾 North Dakota – Remote 🏈 Ohio – Remote 🌪️ Oklahoma – Remote 🦀 Maryland – Remote 🍂 Massachusetts – Remote 🚗 Michigan – Remote ❄️ Minnesota – Remote 🎸 Mississippi – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote ⚓ Rhode Island – Remote 🌴 South Carolina – Remote 🗿 South Dakota – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ⛷️ Utah – Remote 🍁 Vermont – Remote ⚔️ Virginia – Remote ⛰️ West Virginia – Remote 🧀 Wisconsin – Remote 🦬 Wyoming – Remote

💵 $79.8k - $139.6k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Syneos Health

WebsiteLinkedInAll Job Openings

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.

📋 Description

• Work with the Medical Director to develop Medical Management, Medical Data Review, and Eligibility Review Plans • Coordinate 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, patterns, and trends; resolve medical data review issues • Review SAE reports and author medical data queries • Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders • Support trial design and endpoint development • Set up and support SAC, DMC, and adjudication committees • Collaborate on protocols and amendments and participate in governance committee review • Author protocol clarification letters and contribute to study-specific documents • Review and update informed consent • Provide scientific input to project management for data management activities • Monitor clinical data issues, central lab reports, external data, safety information, and critical values • Prepare scientific slides and present protocol information at Investigator Meetings • Coordinate laboratory, biospecimen, and imaging specifications • Participate in database lock activities • Collaboratively plan CSRs and other deliverables with medical writing • Support publications and presentations • Reconcile and review protocol deviation classifications and prepare protocol deviation lists for CSRs • Provide scientific assessments for Operational Reviews • Support Project Management, Statistics, Medical Writing, and other activities to achieve study deliverables • Provide clinical specifications to study teams for vendor interactions • Mentor other Clinical Scientists as needed • Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks related to data integrity and subject safety • Escalate study concerns, at-risk deliverables, and out-of-scope tasks to project leads • Adhere to data privacy guidelines, ICH, GCPs, company policies, SOPs, work instructions, and project plans

🎯 Requirements

• Medical/scientific expertise in infectious disease and HIV • Years of experience and deep expertise in the relevant therapeutic area • Ability to develop medical plans with the Medical Director • Ability to perform medical review of data listings, data visualizations, and SAE reports • Ability to analyze data and identify risks and data patterns/trends • Ability to author medical data queries and review query responses • Experience with trial design and endpoint development • Ability to support SAC, DMC, and adjudication committees • Experience collaborating on protocols, amendments, informed consent, study-specific documents, and clinical study reports • Knowledge of data management activities, including EDC, DRP, and CRFs • Ability to monitor safety data, central lab reports, and external data • Knowledge of ICH and GCP requirements • Adherence to data privacy guidelines, enterprise policies, SOPs, work instructions, and project plans • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• 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