Sr Medical Scientist

Sr Medical Scientist - PhD is required and experience working in a CRO with real world evidence studies - Mexico, Brazil and Colombia. This is a home based role.

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier 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, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

• 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 all data privacy guidelines, ICH and GCPs, enterprise policies, and project plans. Adheres to customer policies and standard operating procedures as required.
• May manage a limited number of direct reports. May participate or conduct interviews.

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 brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

• PhD is required.
• Experience working in a CRO with real world evidence studies.
• Location: Mexico, Brazil, and Colombia; Home Based.

Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks as needed. The Company will determine what constitutes equivalent qualifications. The Company is committed to compliance with applicable laws and policies.