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Sr Medical Scientist - PhD is required and experience working in a CRO with real world evidence[...]

Sr Medical Scientist - PhD is required and experience working in a CRO with real world evidence[...]

Syneos HealthRegión Metropolitana de Santiago, Chile
Hace 10 días
Descripción del trabajo

Overview

Sr Medical Scientist - PhD is required and experience working in a CRO with real world evidence studies - Mexico, Brazil and Colombia. Home Based.

Description

Sr Medical Scientist - PhD is required and experience working in a CRO with real world evidence studies - Mexico, Brazil and Colombia Home Based.

About Syneos Health

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 all we do. We strive to simplify and streamline our work to be easier to work with and to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to accelerate the delivery of therapies and change lives.

Why Syneos Health

  • We are passionate about developing our people through career development, training, and a total rewards program.
  • We maintain a Total Self culture—authenticity and inclusion across the organization.
  • We value diversity of thought, background, and perspective to create a sense of belonging.

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; analyzes data to identify risks and 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, and 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, and 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, objectives, and quality of deliverables to ensure milestones and timelines are met. Serves as primary interface between internal team, customers, and vendors in 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.
  • Gains basic understanding of ongoing protocol designs and disease terminology and pathology.
  • Adheres to all data privacy guidelines, ICH, and GCPs, enterprise policies, SOPs, and project plans. Adheres to customer policies as required.
  • May manage a limited number of direct reports and may participate in interviews.
  • Qualifications

  • PhD required.
  • Experience working in a CRO with real world evidence studies.
  • Ability to work in a home-based role covering Mexico, Brazil and Colombia.
  • Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Research, Analyst, and Information Technology
  • Summary : Partners with Medical Director to provide clinical and scientific input to clinical development programs, ensuring scientific integrity and data quality of trials, and collaborating on data reviews and Medical Management activities.

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    Sr Medical Scientist • Región Metropolitana de Santiago, Chile

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