Lakshmi Bai

Clinical Specialist

• Drafting the protocol for the clinical trials.
• Drafting the clinical manuscript for the publications .
• Coordinating with the clinicians and demo of the product.
• Develop study procedures, methodology and instructions for clinical trials staff, as well as design data collection tools (case report forms);
• Submission of clinical trial documents for review and approval by those ethics committees.
• Recruit and enroll study participants.
• Coordinating with Clinicians /investigators on conducting the clinical trail
• Assist doctors in product usage while performing the procedures.
• To collect clinical literature review
• Looking into clinical conferences and attending .
• Demonstration of product usage to the Clinician's.
• Looking into competitor updates .
• Making phantom models for validation & getting feedback from clinicians
• Maintaining and recording the clinical data of the clinicals trails.
• Creating the data set for the verification testing .
• Preparing phantoms models for validation and submitted documents for 510K submission .

QA:

• Establish the quality management system and procedures.
• Review of Quality policy and quality objectives periodically
• Coordinating with the cross functional team on follow up actions and ensuring the action items are closed.
• Documenting new and existing processes
• Coordinate and support on-site audits conducted by external providers
• Evaluate audit findings and implement appropriate corrective actions

MR

• Preparing management review meeting schedule and conducting management review meetings
• Preparing audit schedules, conducting internal audits , preparing audit reports, writing nonconformity reports..
• Communicating to the top management on quality issues / Non-conformities & audit reports
• Scheduling supplier audit .
• To maintain master list of documents
• To control, distribute, issue, retrieval, destruction and storage of documents.

• Given Demo of Conceptual Prototypes to the doctors and collected feedback; Incorporated those findings in the product development
• Assisted in providing new ideas to enhance both product performance and process efficiency
• Authored documents for Biotechnology Ignition Grant Scheme (BIG) & Small Business Innovation Research Initiative (SBIRI).
• Patents searching
• Clinical literature reviewing .