Clinical Scientist - Respiratory

Syneos Health, Inc.; Washington; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Syneos Health, Inc. is seeking a Medical Data Review professional to collaborate with Medical Directors in developing medical plans and reviewing data. You will coordinate input from external experts, assess data for risks, and document findings.

Responsibilities include authoring medical data queries, supporting safety reviews, and liaising with study teams to ensure data integrity and regulatory compliance. Remote work options may apply within the U.S.

Responsibilities

• Works with Medical Director to develop medical plans and coordinates input from outside experts for Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan.
• Performs regular and ad-hoc medical review of data listings and data visualization; analyzes data to identify risks and trends; supports documentation of medical reviews.
• Authors medical data queries and reviews query responses; approves query closure with Medical Director.
• May assist Medical Director in patient profiles review, protocol deviation review, and creation of Medical Review Summary reports.
• Partners with Medical Directors for medical data review meetings and safety review meetings including slide preparation.
• Manages project scope, objectives, and deliverables; serves as primary interface between internal team, customers, and vendors in medical data review and eligibility review.
• Collaborates with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management to identify risks to data integrity and subject safety; escalates concerns as needed.
• Attends Trusted Process meetings and may participate in internal and external audits.
• Gains basic understanding of ongoing protocol designs and disease terminology; adheres to ICH, GCP, privacy guidelines, and enterprise policies.

Job description

Updated: Yesterday
Location: Remote, WA, United States
Job ID:25108957-OTHLOC-1500-2DWA-2DR

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.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are 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.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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.
• 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 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.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of