[Hiring] Senior Medical Scientist @Syneos Health Careers

Role Description

Sr Medical Scientist - Min 3 years of previous experience in development of protocol design - English Advanced - Brasil, Mexico, Argentina, Chile, Peru - 100% Remote

• 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 present 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 Committee 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 limited number of direct reports. May participate or conduct interviews.

Qualifications

• Min 3 years of previous experience in development of protocol design.
• English Advanced.
• Experience in clinical and scientific input to early and late-stage clinical development programs.

Requirements

• Strong scientific knowledge to ensure the scientific integrity and data quality of clinical trials.
• Ability to collaborate with Medical Director(s) and other team members on data reviews.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.