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
why 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 everything we do. We strive to simplify and streamline our work to better serve our clients and patients.
we value a diverse, inclusive workforce and are committed to developing our people through career development, training, and recognition. Our culture emphasizes collaboration, accountability, and a focus on improving lives through innovative therapies.
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 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.
* 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, 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 across clinical operations, data management, drug safety and pharmacovigilance, and project management to identify risks related to data integrity and subject safety. Escalates concerns in a timely manner.
* attends and presents at trusted process meetings and may participate in internal and external audits.
* maintains basic understanding of ongoing protocol designs and disease terminology.
* adheres to data privacy guidelines, ich, gcps, enterprise policies, sops, and project plans; adheres to customer policies and procedures as required.
* may manage a limited number of direct reports and may participate in interviews.
qualifications
* phd in a relevant field and experience in real-world evidence studies.
* experience working in a cro environment.
* strong medical and data review skills, with ability to coordinate input from external experts.
* ability to work in a home-based role within mexico, brazil and colombia.
additional information
tasks, duties, and responsibilities listed are not exhaustive. The company may assign other tasks as needed. The organization is committed to compliance with applicable laws and regulations and to providing reasonable accommodations as required.
seniority level
* mid-senior level
employment type
* full-time
job function
* research, analyst, and information technology
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