Associate Director, Clinical Operations (Retina Program)

New

Remote, United StatesFull-TimeManager

Salary179,000 - 196,000 USD per year

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Job Details

Experience: B.S./B.A. with 9+ years of industry experience in clinical development with a minimum of 3 years managerial experience, or M.A./M.S. with 4+ years of experience.
Required Skills: GCPBudget management

B.S./B.A. in Life Science or related discipline required; advanced degree preferred.
9+ years of industry experience in clinical development for B.S./B.A. holders; 4+ years for advanced degree holders.
Minimum of 3 years of managerial experience.
Proven experience in late-phase clinical trial execution.
Thorough knowledge and understanding of FDA and ICH Guidelines, GCP, and medical terminology.
Ability to develop and manage functional and clinical trial-specific budgets.
Demonstrated ability to recruit, retain, and motivate clinical operations personnel.
Strong interpersonal skills with the ability to present complex information to diverse audiences.
Proficiency in written communication and ability to summarize information effectively.
Clinical Research certification is preferred.

Partner with the Director of Clinical Operations to manage clinical programs in alignment with corporate objectives.
Lead the direction, planning, and execution of clinical trials and data collection.
Provide mentorship and guidance to Clinical Trial Managers (CTMs) and junior staff.
Oversee the day-to-day activities of Clinical Trial Operations and Clinical Data Management.
Collaborate on annual budget planning, re-forecasts, and vendor outsourcing strategies.
Ensure clinical trials are inspection-ready and managed by cross-functional Study Execution Teams (SET).
Partner with Quality, Regulatory Affairs, and Clinical Sciences on protocol development and regulatory submissions.

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