AD, Clinical Operations – Contract

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with the Director of Clinical Operations to design and oversee clinical programs that align with corporate goals and timelines.

• Lead the planning, execution, and analysis of clinical trials and data collection efforts.

• Create and track timelines, budgets, risks, and mitigation strategies for clinical trials and programs.

• Provide guidance and mentorship to Clinical Trial Managers and junior staff members.

• Supervise the daily activities of the Clinical Trial Operations and Clinical Data Management teams.

• Work together on annual budget preparation, quarterly budget evaluations, and re-forecasting.

• Design, implement, and manage strategies for outsourcing clinical vendors.

• Select and manage vendors that support clinical trial initiatives.

• Ensure that clinical trials maintain inspection readiness and are actively overseen by cross-functional Study Execution Teams.

• Act as a subject matter expert in Clinical Operations for product cross-functional core teams when necessary.

• Collaborate with Quality teams to ensure inspection preparedness.

• Partner with Regulatory Affairs and Clinical Sciences on regulatory submissions and compliance obligations.

• Address escalated study challenges and devise risk mitigation plans.

• Coordinate the development and upkeep of clinical standard operating procedures.

• Assist in the development of protocols, amendments, study documents, plans, and operational execution.

• Participate in the selection of CROs, sites, and vendors, and monitor their progress and contingency plans.

• Contribute to the enhancement of Clinical Operations processes and procedures while managing clinical resources.

⛳️ Requirements

• A B.S./B.A. in Life Science or a related field is required.

• An advanced degree (M.S./M.A., MPH, MHS, MBA) is preferred.

• Clinical Research certification is preferred but not mandatory.

• B.S./B.A. with over 9 years of industry experience in clinical development, including at least 3 years in a managerial role, or M.A./M.S. with over 4 years of relevant experience.

• A minimum of 1 year of experience in ophthalmology trials.

• Experience in late-phase trials.

• Relevant experience in executing clinical trials across all phases.

• Demonstrated ability to recruit, retain, organize, and motivate personnel in clinical operations.

• Proficient in communicating updates and priorities to Clinical Operations and Development Leadership, advocating for necessary budgets and resources.

• Capable of managing and overseeing programs that have a company-wide impact.

• Skilled in developing and managing functional and clinical trial-specific budgets.

• Ability to prioritize and handle a large workload with meticulous attention to detail.

• Strong interpersonal, communication, and presentation skills.

• Comprehensive knowledge of FDA and ICH Guidelines, GCP, medical terminology, and clinical trials.

• Flexibility and adaptability to meet changing business requirements.

• Ability to write clearly and summarize information efficiently.

• Must be capable of presenting complex information to diverse audiences.

• Sedentary work with the ability to perform repetitive actions involving wrists, hands, fingers, typing, and speaking.

🏝️ Benefits

• Opportunities for career development.

• Equal employment opportunities for all individuals.

• Anticipated travel of 20%, or as required by trial needs.