Nextvel Consulting Llp

Role & responsibilities Independently manage 4-5 projects (CRPL) and 10-15 projects (PM) level with full accountability for quality, timelines, and budgets. Responsibilities include preparing clinical trial documents like clinical study protocols, research participant information sheet & consent forms, Case Report Forms, and Investigators Brochures, as well as preparing CTD modules, Study Plans etc. Negotiate Contracts with Sites including site budgets, evaluate site feasibility data, and overseeing all pre-study and post-study activities. The role will require to support ethics committee and regulatory submissions, maintain liaison with regulatory agencies, provide training to site staff and project team on study protocol, plans and procedures, ICH GCP, and relevant regulations. Additional duties include preparing presentations for investigator meetings, regulatory meetings, reviewing site visit reports, and coordinating safety reporting to ensure compliance with regulatory requirements. The role requires close collaboration with team members, like CRAs, regulatory associates, sponsors team members, principal investigators and site team members. The candidate should ensure accurate data verification, support data cleaning and analysis, oversee Investigational Product management, and maintain completeness of Trial Master Files. Should have a strong understanding of clinical research regulations and guidelines. Should be a team-player, manage teams effectively and willing to travel.