Study Manager - Ophthalmology

Updated: Yesterday
Location: Morrisville, NC, United States
Job :

• Project Leadership and Delivery – manage a project as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements.
• 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.
• Responsible for quality and completeness of 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; oversee 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 potential project manager.
• May be required to line‑manage other project management team members and clinical monitoring staff.

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

Roles within the Clinical Project Management job family are responsible for planning, directing, creating, and communicating clinical study timelines. 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 operate within standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations.

They adopt and implement the clinical development strategy as outlined by the clinical teams, may develop trial recruitment strategies, and provide strategic vision and tactical direction across the organization.

• Company car or car allowance
• Health benefits – medical, dental, and vision
• Company match 401(k)
• 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

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. 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.