Study Manager - Ophthalmology

Syneos Health; United States; On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Company car or allowance

Medical, dental, and vision benefits

401(k) company match

Employee Stock Purchase Plan

Flexible paid time off (PTO)

Job summary

Syneos Health is seeking a Study Manager specialized in Ophthalmology to oversee clinical research studies. Responsibilities include managing project timelines, ensuring regulatory compliance, and serving as the primary liaison between the company and clinical partners.

The ideal candidate will hold a Bachelor's Degree in a relevant field and possess strong organizational and communication skills, as well as knowledge of Good Clinical Practice guidelines.

Benefits include a company car or allowance, health benefits, and a flexible time-off policy.

Qualifications

• Bachelor’s Degree (or equivalent) in life sciences, medicine, pharmacy, nursing.
• CRO experience preferred; knowledge of GCP/ICH guidelines.
• Excellent communication and interpersonal skills.

Responsibilities

• Manage interdisciplinary clinical research studies.
• Ensure compliance with GCP and regulatory requirements.
• Act as a liaison between company and customer.

Skills

Organizational skills

Time management

Communication

Interpersonal skills

Therapeutic area expertise

Education

Bachelor's Degree in life sciences, medicine, pharmacy, or nursing

Job description

Study Manager - Ophthalmology

Job Responsibilities

• Project Leadership and Delivery. Manages a project as a project manager overseeing interdisciplinary clinical research studies and ensures compliance with GCP, relevant SOPs, and regulatory requirements.
• Acts as a primary liaison between the Company and the Customer to ensure timely study launch, conduct, and closeout according to contractual agreements.
• Lead project team to ensure quality, timelines, and budget management.
• Accountable for the financial performance of each project; coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues.
• Ensure studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements. Accountable for all project deliverables for each assigned project.
• Responsible for quality and completeness of the Trial Master File (TMF) for assigned projects.
• Accountable for maintenance of study information on a variety of databases and systems.
• Responsible for study management components of inspection readiness for all aspects of the study conduct; oversight for development and implementation of project plans.
• Plan, coordinate, and present at internal and external meetings; prepare project management reports for clients and management.
• Develop contingency planning and risk mitigation strategies to ensure successful delivery of study goals.
• Develop strong relationships with current clients to generate new and/or add‑on business for the future.
• May participate in bid defense meetings where presented as a potential project manager.
• May be required to line‑manage other project management team members and clinical monitoring staff.

Qualifications

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, medicine, pharmacy, nursing, or equivalent combination of education and experience.
• Clinical research organization (CRO) and relevant therapeutic experience preferred; strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.
• Strong organizational skills.
• Strong ability to manage time and work independently.
• Direct therapeutic area expertise.
• Ability to embrace new technologies.
• Excellent communication, presentation, interpersonal skills, both written and spoken.
• Ability to travel as necessary (approximately 25%).

Benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, company match 401(k), eligibility to participate in an Employee Stock Purchase Plan, eligibility to earn commissions/bonuses 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.

Summary

Roles within the Clinical Project Management job family are responsible for planning, directing, creating, and communicating clinical study time‑lines. They gather input from cross‑functional teams and create plans that help the team produce deliverables on schedule. They ensure consistency of clinical study and processes across clinical trials, oversee and resolve operational aspects of clinical trials in conjunction with project teams, and adhere to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. This includes site and vendor selection, preparing clinical trial budgets, ensuring studies are conducted within protocols, monitoring progress, and following up with team members and line managers when issues develop. They implement and prepare the clinical development strategy as outlined by the clinical teams and may develop trial recruitment strategies.

We remain 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. This position and its duties 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 employees.