Sr Medical Scientist (Location : Argentina, Chile, Guatemala, Peru, Costa Rica)

Overview

Sr Medical Scientist (Location : Argentina, Chile, Guatemala, Peru, Costa Rica).

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, and we aim to simplify and streamline our work to be easier to work with for both customers and employees. Whether you join a Functional Service Provider partnership or a Full-Service environment, you will collaborate with problem solvers to help our customers achieve their goals in a fast-paced, changing environment.

Work here matters everywhere.

Responsibilities

• 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. Pro-actively identifies and resolves medical data review issues as they arise.
• 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. Escalates ongoing and newly developed study concerns such as at-risk project deliverables and out of-scope tasks to the project leads in a timely manner.
• Attends and presents 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 Council 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.
• May manage a limited number of direct reports. May participate or conduct interviews.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information : Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and responsibilities at its sole discretion. Equivalent experience, skills, and / or education will be considered. The Company will determine what constitutes equivalent qualifications. This description is intended to comply with applicable local laws and regulations. The Company is committed to compliance with disability legislation when applicable.

Requirements

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