Clinical Scientist – Oncology

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🌵 Arizona, Maine, +3 more states – Remote

🌵 Arizona – Remote 🦞 Maine – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote ⚓ Rhode Island – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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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

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan) • Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans • Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews • Authors medical data queries and reviews query responses, approves query closure in association with Medical Director • May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed • Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed • Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met • Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review • Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety • Attends at Trusted Process meetings and may participate in internal and external audits • Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology • Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans • Adheres to customer policies and standard operating procedures, as required in project plans

🎯 Requirements

• Works with Medical Director to develop medical plans (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan) • Engages with outside experts/consultants/advisors to coordinate the acquisition of necessary medical/scientific input to prepare the respective medical plans • Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes the data to identify risks and data patterns/trends and supports documentation of medical reviews • Authors medical data queries and reviews query responses, approves query closure in association with Medical Director • May assist Medical Director in patient profiles review, scientific review of other study level data, protocol deviation review, creation of Medical Review Summary report as needed • Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed • Manages project scope of work, objectives, and quality of deliverables to ensure the project specific milestones and timelines are met • Serves as primary interface between internal team, customers, and vendors in the areas of medical data review and eligibility review • Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management (set-up and/or lead meetings as appropriate) to identify risks related to data integrity and subject safety • Attends at Trusted Process meetings and may participate in internal and external audits • Acquires basic understanding and knowledge of ongoing protocol designs and disease related terminology and pathology • Adheres to all data privacy guidelines, International Committee on Harmonization (ICH), and Good Clinical Practices (GCPs), all enterprise policies, standard operating procedures, work instructions, and project plans • Adheres to customer policies and standard operating procedures, as required in project plans

🏖️ Benefits

• Health benefits to include Medical, Dental and Vision • 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