Clinical Scientist - Ophthalmology

Syneos Health, Inc.; Arizona; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Company car

Health benefits

401k match

Stock purchase plan

Bonus eligibility

Flexible PTO

Job summary

Syneos Health is seeking a Clinical Scientist in Ophthalmology to support medical data review, data visualization, and medical plan development. The role collaborates with Medical Directors and external experts to ensure data integrity and timely delivery of study deliverables.

The position emphasizes adherence to ICH and GCP guidelines, cross-functional teamwork, and proactive risk assessment across clinical data reviews and safety reviews.

Qualifications

• Experience conducting medical data reviews and listing analyses.
• Proven ability to review data for accuracy and identify patterns.
• Familiarity with data visualization to communicate study findings.

Responsibilities

• Collaborate with Medical Director to develop medical plans and coordinate input from external experts.
• Perform regular and ad-hoc medical reviews of data listings and visualizations.
• Draft medical data queries and oversee responses and closure with Medical Director.
• Assist in patient profiles review and protocol deviation review as needed.
• Prepare materials for Medical Review and Safety review meetings.
• Manage project scope, milestones, and liaise with customers and vendors.
• Identify data integrity and safety risks with cross-functional teams.
• Participate in audits and maintain compliance with ICH and GCP guidelines.

Skills

Medical data review

Data visualization analysis

Data integrity vigilance

Project collaboration

Education

Advanced degree in life sciences

Tools

Statistical software

Job description

Updated: Today
Location: Remote, AZ, United States
Job ID:25108955-OTHLOC-1500-2DAZ-2DR

Clinical Scientist - Ophthalmology

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.

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.

The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.

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 Directors and other team members on data reviews and other Medical Management activities to ensure the successful execution and conduct of clinical trials.

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 Americas with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

http://www.syneoshealth.com