Clinical Scientist, Medical Monitoring – Oncology – Phase I

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $67.7k - $115.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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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 plans, including Medical Management, Medical Data Review, and Eligibility Review Plans • Engage outside experts, consultants, and advisors to obtain medical/scientific input for medical plans • Perform regular and ad-hoc medical review of data listings and visualizations • Analyze data to identify risks, patterns, and trends; 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 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 data integrity and subject safety risks • 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 • May manage a limited number of direct reports and participate in or conduct interviews

🎯 Requirements

• 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 • Ability to analyze medical data listings and data visualizations to identify risks and patterns/trends • Ability to author medical data queries and review query responses • Knowledge of data privacy guidelines, ICH, and GCPs • Ability to adhere to enterprise and customer policies, standard operating procedures, work instructions, and project plans • Ability to collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management • Equivalent experience, skills, and/or education may be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive work 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