G.M. - CLINICAL RESEARCH

As a General Manager reporting to the Sr. VP of Clinical Research, you will be responsible for overseeing various aspects of clinical trials and BA-BE studies. With an educational background of MBBS and MD, you are expected to bring 15-20 years of experience to the role. Your primary duties will include preparing, reviewing, and approving clinical trial documents, providing medical support to the study team, and assisting in regulatory approvals in NDAC Meetings. Your role will also involve CRO evaluation and selection for outsourcing clinical research projects, as well as preparing and implementing CAPA. Real-time management of SAEs and monitoring responsibilities will be crucial aspects of your job. Additionally, you will be involved in developing clinical trial documents, assisting in site feasibility and selection, and conducting site initiation, interim monitoring, and close-out visits. In the realm of medical writing, you will be responsible for preparing medico-regulatory documentation, SmPC, package inserts, patient information leaflets, clinical overviews, summaries, expert reports, safety efficacy reports, and more. Your technical skills should include a solid understanding of medical concepts, clinical trial designs for vaccines, pharmacokinetics, and safety evaluation. Being a team player with attention to detail, good analytical skills, and effective communication abilities will be essential for success in this role. Overall, your role as a General Manager in Clinical Research will require a project-oriented approach, strong scientific acumen, and the ability to collaborate effectively with various stakeholders to ensure the successful execution of clinical trials and research projects.,