Yogitha P

About Yogitha P

As a Clinical Project Manager and Medical Affairs professional with over 9 years of experience across CROs, pharmaceutical companies, and academic research, I specialize in leading cross-functional teams and ensuring the successful execution of clinical trials. My core strengths lie in central monitoring, site risk assessment, and protocol compliance. I\'ve managed complex projects from start-up to close-out, handled regulatory submissions, implemented Standard Operating Procedures (SOPs), and collaborated closely with sponsor representatives to drive timelines and achieve optimal outcomes. I bring hands-on experience with tools like Medidata, eTMF, and clinical analytics dashboards, alongside financial responsibilities such as forecasting, billing, and scope amendments. Known for my proactive communication, leadership, and quality-focused mindset, I\'ve consistently delivered zero-error results and improved operational efficiency across projects. Now, I\'m looking to contribute to global clinical research projects where I can continue to lead with strategy, compliance, and compassion. Open to Clinical Project Manager or Medical Affairs roles in pharma, CRO, or medtech sectors. Let’s connect!

Experience

1. Chief Medical Affairs Lead

   Nesa Medtech

   Dec 2023 — Present · Bengaluru, IN

   Planning & execution of clinical strategy i.e. execution of clinical studies, publication, training workshops, participation in conferences etc.Drive the execution of clinical studies i.e. Protocol Preparation & Documentation, SITE & PI Identification, IEC Approval, Execution & Monitoring of studies & publication.Drafting and publishing clinical study reports, summaries, and other medical documents.Assist in incorporating a diversified clinical advisory board.Facilitate meetings, coordinate and gather inputs from the clinical advisory board.Act as a liaison between internal teams and external clinical advisory boards.Maintain accurate and organized records of all clinical advisory board member activities.Assist in preparing clinical materials such as posters and presentations for the clinical advisory team to present at conferences.Participate in the selection process for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained.Allocation of resources to clinical research projects by assigning staff based on their experience and training.Identify quality risks and issues and create appropriate corrective action plans to prevent or correct staff performance deficiencies.Managing the quality of assigned staff\'s clinical work through regular review and evaluation of work product.Contribute to the development of clinical marketing materials, ensuring alignment with clinical data and messaging.Collaborate with the marketing team to create materials that effectively communicate product benefits to healthcare professionals.Assist in the preparation of regulatory submissions and responses as required.

Education

• Sri Chaitanya College of Education

  10-12

• A.B.Shetty Memorial Institute of Dental Sciences

  BDS

  2007 — 2012

• Sri Krishnaveni Talent School

  X Standard

• SDM College of Dental Sciences and Hospital

  Master's degree

  2016 — 2019