Sonal Shekhawat

• Oversaw all operational aspects of clinical trials in the U.S., ensuring compliance with protocols and regulations.
• Provided medical and scientific input for developing study documents, including investigational plan
• Ensure protocol and all auxiliary documents, including Manual of Procedures, Informed Consent Form, Investigator Brochure, Statistical Analysis Plan etc. are written in high quality.
• Managed development and implementation of patient recruitment and retention strategies for trials.
• Led proactive site performance management, including data collection and trial master file reviews.
• Collaborated with external vendors on clinical trial status and communicated progress to global teams.
• Ensure trials are carried out according to the protocol, SOPs, and ISO/GCP regulations, and documents are inspection-ready.
• Interface with different departments to ensure that clinical activities are in line with overall strategic goals including Quality, R&D, Marketing and Sales.
• Forecasted trial resource needs and managed budget development and tracking.
• Medical Advisor for the Vigilance and complaints department.
• Provide medical/scientific input to cross-functional teams during the Design and Development phase of the products and as requested.
• Review Clinical evaluation Plans (CEP), Clinical Evaluation Reports(CER), Clinical Investigation Reports (CIR), PMCF plans, IFU( Instructions for Use), DFMEA, UFMEA, Risk Management Plans.

Accountable for all operational aspects in the set-up and management of clinical trials in the US.

Oversaw clinical trial execution, including data collection and adverse event analysis, budget management, IRB/IEC communication, and protocol adherence; ensured ethical and regulatory compliance and maintained accurate study documentation.

Contributed to a prospective glaucoma laser study, supporting protocol design, chart review, data collection, statistical analysis, and interpretation.

• Diagnosed and treated various eye conditions using advanced diagnostic tools.
• Performed cataract surgeries and other ophthalmic procedures efficiently.

• Managed patient care activities in a fast-paced hospital environment.
• Provided mentorship and training to junior residents and medical students.