Sr Medical Scientist

Há 3 dias

São Paulo, Brasil Syneos Health Tempo inteiro

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 unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient in everything we do. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

Job 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 to identify risks related to data integrity and subject safety. Escalates ongoing and newly developed study concerns in a timely manner.
  • Attends and presents at Trusted Process meetings and may participate in internal and external audits.
  • Adheres to data privacy guidelines, ICH, and GCPs, enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures as required.
  • May manage a limited number of direct reports and may participate in interviews.
Qualifications
  • PhD is required.
  • Experience working in a CRO with real world evidence studies.
  • Location flexibility: home-based in Argentina, Chile, Guatemala, Peru, or Costa Rica.
Additional Information
  • Summary: Partners with Medical Directors to provide clinical and scientific input to early and late-stage clinical development programs, ensuring scientific integrity and data quality of clinical trials.
  • Employment type: Full-time
  • Seniority level: Mid-Senior level
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