Global Senior Manager Clinical Research (Ophthalmology)

Direct Staffing Inc; Milpitas (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

SmartRecruiters, Inc. in Milpitas, CA, seeks a Sr. Mgr, Clinical Research to lead worldwide investigational plans for ophthalmology products, ensuring compliance with global guidelines.

The role directs studies from protocol design to final reports, manages budgets and staff, and maintains GCP/SOPs in line with ISO/FDA requirements. This position reports to the Director of Clinical Research and requires 8–10 years in clinical research with strong leadership and regulatory collaboration.

Qualifications

• 8–10 years of directly related clinical research planning and execution experience.
• Experience in ophthalmology with expertise in statistics and study design.
• Strong supervisory skills and ability to interact with all levels of the organization; interact with physicians at peer level.

Responsibilities

• Develops the worldwide clinical investigational plan and strategy.
• Directs and ensures completion of clinical studies from design to final report writing.
• Maintains GCP/SOPs in compliance with ISO/ANSI, FDA and other regulatory guidelines.
• Manages study budgets and personnel resources for clinical studies.
• Hires, trains, and motivates personnel; coaches career development.
• Interacts with FDA and other worldwide regulatory agencies to achieve product approval.

Skills

Clinical trial management

Regulatory compliance

Budget management

Leadership

FDA interactions

Statistics & study design

Education

BA/BS or equivalent

Advanced degree preferred (MS/PhD/MD/OD/PharmD)

Job description

SmartRecruiters, Inc. in Milpitas, CA, seeks a Sr. Mgr, Clinical Research to lead worldwide investigational plans for ophthalmology products, ensuring compliance with global guidelines.

The role directs studies from protocol design to final reports, manages budgets and staff, and maintains GCP/SOPs in line with ISO/FDA requirements. This position reports to the Director of Clinical Research and requires 8–10 years in clinical research with strong leadership and regulatory collaboration.