Sr Medical Scientist

Summary

Partners with Medical Director to provide clinical and scientific input to early and late-stage clinical development programs with an emphasis on protocol-specific requirements and ensuring the scientific integrity and data quality of clinical trials by using scientific knowledge. Collaborates with Medical Director(s) and other team members on data reviews, and other Medical Management activities to ensure the successful execution and conduct of clinical trials.

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. 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.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http : / / www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

Partners with Medical Director to provide clinical and scientific input to early and late-stage clinical development programs with an emphasis on protocol-specific requirements and ensuring the scientific integrity and data quality of clinical trials by using scientific knowledge. Collaborates with Medical Director(s) and other team members on data reviews, and other Medical Management activities to ensure the successful execution and conduct of clinical trials.

At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your pastexperience doesn’t align perfectly, we encourage you to apply anyway. At times, we take intoconsideration transferrable skills from previous roles. We also encourage you to join our Talent Network to stay connected to additional career opportunities.

Discover what our 29,000 employees already know : work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Syneos Health (Nasdaq : SYNH) is a leading 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. We support a diverse, equitable and inclusive culture.

Phone : 919 876 9300

Fax : 919 876 9360

Toll-Free : 866 462 7373

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at : Email : jobs@syneoshealth.com. One of our staff members will work with you to provide alternate means to submit your application.

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