Clinical Scientist - Ophthalmology

Syneos Health/ inVentiv Health Commercial LLC; Tennessee; On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental, andV

Company match 401k

Eligible for Employee Stock Purchase

Bonus/commission eligibility

Flexible PTO and sick time

Job summary

Syneos Health/ inVentiv Health Commercial LLC is seeking a Clinical Scientist - Ophthalmology to support medical planning, data review, and cross-functional collaboration. You will work with the Medical Director to develop Medical Management Plans and review data listings, contributing to safety and scientific integrity.

The role involves coordinating with study teams across Clinical Operations, Data Management, Drug Safety, and Pharmacovigilance to identify data risks, prepare reports, and

Responsibilities

• Develop medical plans in collaboration with Medical Director (Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan).
• Perform regular and ad-hoc medical review of data listings and data visualization; analyze data to identify risks and trends; support documentation of reviews.
• Author medical data queries and review responses; approve query closures with Medical Director.
• Assist Medical Director in patient profile reviews, scientific review of study data, protocol deviation reviews, and Medical Review Summary reports as needed.
• Partner with Medical Directors for medical data review meetings and safety review meetings including slide preparation as needed.
• Manage project scope of work, objectives, and deliverables to meet milestones; act as primary interface with internal team, customers, and vendors in medical data review and eligibility review.
• Collaborate with study team members (Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, Project Management) to identify data integrity and subject safety risks; escalate concerns timely.
• Attend trusted process meetings and participate in internal and external audits.
• Acquire understanding of protocol designs and disease-related terminology and pathology.
• Adhere to data privacy, ICH, GCPs, SOPs, and project plans; comply with customer policies and SOPs.

Job description

Clinical Scientist - Ophthalmology

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 acquisition of necessary medical/scientific input to prepare respective medical plans.
• Performs regular and ad-hoc medical review of data listings and data visualization as needed; analyzes 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 project-specific milestones and timelines are met; serves as primary interface between internal team, customers, and vendors in 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 to project leads in a timely manner.
• Attends 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, ICH, GCPs, enterprise policies, SOPs, work instructions, and project plans; also adheres to customer policies and SOPs as required in project plans.

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.

Benefits

• 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
• Flexible paid time off (PTO) and sick time (availability may vary by state)

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.