Centralized Monitoring Lead

The Centralized Monitoring Lead position requires a minimum of 4 plus years of experience in Clinical Research Associate (CRA) and Clinical trials monitoring. The work location can be in Bangalore, Thane, Pune, Ahmedabad, Kochi, or Hyderabad, and the work mode is Hybrid/Office Based with a shift from 2.00 pm to 11.00 pm. The key skills required for this role include Onsite/Remote/Risk Based Monitoring, Clinical Research, and Clinical Trials. As the Centralized Monitoring Lead, you will provide leadership to the centralized monitoring team in collaboration with project and clinical leads and other functional teams. Your primary responsibility will be to ensure the successful delivery of projects while meeting sponsor expectations, optimizing speed, quality, and cost of delivery, and adhering to standard operating procedures. You will also oversee clinical deliverables across all trial phases, develop study management plans and risk assessments, monitor site performance and key risk indicators, and coordinate cross-functional teams to meet project milestones. In addition to managing the clinical deliverables, you will be responsible for quality assurance, leading data review processes, and ensuring audit readiness at all times. You may also need to take up Clinical lead activities, manage project resources, conduct periodic reviews of site activities, and provide expertise support in Centralized monitoring studies. Furthermore, you will act as a mentor or coach for Technical Solution Specialists (TSS) and monitor site performance to make recommendations for corrective actions. To be successful in this role, you must have a minimum of 5 years of relevant experience or a Medical degree with a minimum of 4 years of clinical trial experience. Advanced knowledge of clinical trial conduct, clinical research regulatory requirements, and Good Clinical Practice (GCP) guidelines is essential. Strong communication skills, attention to detail, and the ability to work on multiple projects while managing competing priorities are also crucial. Additionally, you should have in-depth therapeutic and protocol knowledge, the ability to work across cultures and geographies, and maintain effective working relationships with coworkers, managers, and clients. Educationally, a Bachelor's degree in clinical, life sciences, mathematical sciences, or a related field is required. A nursing qualification or allied medical degree would also be considered beneficial for this role.,